Current Drug Shortages: Cocaine Topical Solution

Wednesday, 01 February 2012 11:07

 The information provided in this section is provided voluntarily by manufacturers.  FDA cannot require firms to report the reason for shortage or duration of the shortage or any other information about shortages.  FDA appreciates all information provided by manufacturers.  We post information about shortages as soon as we receive it from the manufacturers.  To report information about shortages or supply issues, manufacturers can send updates to This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  Healthcare professionals and patients are also encouraged to notify us of shortages at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Acetylcysteine Inhalation Solution (updated 1/23/2012)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

100 mg/mL; 30 mL vial
(NDC 0409-3307-03)
200 mg/mL; 30 mL vial
(NDC 0409-3308-03)

Manufacturing delay.

Product 100 mg/mL; 30 mL vial (NDC 0409-3307-03):  next delivery April.

 

Product 200 mg/mL; 30 mL vial (NDC 0409-3308-03):  next delivery April.

 

Please check with your wholesaler for available inventory.

Roxane Laboratories
1-614-276-4000

200 mg/mL, 10 mL (NDC 00054-3028-02), 200 mg/mL, 30 mL (NDC 00054-3026-02)

Manufacturing Delay

Roxane Laboratories has all acetylcysteine inhalation solution presentations on backorder and the company cannot provide an anticipate release date.

American Regent/Luitpold
631-924-4000

100 mg/mL, 4 mL (NDC 00517-7504-25), 100 mg/mL, 10 mL (NDC 00517-7510-03), 200 mg/mL, 4 mL (NDC 00517-7604-25), 200 mg/mL, 10 mL (NDC 00517-7610-03), 200 mg/mL, 30 mL (NDC 00517-7630-03)

Manufacturing delaysAmerican Regent is releasing acetylcysteine inhalation solution as it becomes available.

 

Alcohol Dehydrated (Ethanol > 98%) (updated 12/16/2011)

Company/ProductsReasonRelated Information
American Regent/Luitpold:
631-924-4000

1 mL ampule, package of 10 (NDC 00517-8571-10); 5 mL ampule, package of 10 (NDC 00517-8575-10)

Manufacturing delays1ml ampules being released.
Akorn Pharmaceuticals
1-800-932-5676

(NDC 17478-0503-05)

n/aAkorn has Alcohol Dehydrated (Ethanol > 98%) available in a 5 mL vials.

 

Alfentanil Injection (1/27/2012)

Company/ProductsReasonRelated Information
Akorn Pharmaceuticals
1-800-932-5676

0.5 mg/ml; 2ml ampule (NDC 17478-0067-02)

0.5 mg/ml; 5ml ampule (NDC 17478-0067-05)

Increased demand

Limited emergency supply of Alfenta 2 mL and 5 mL ampules.

2 mL ampules are available, 2012.

5 mL ampules have a production scheduled for late 1Q 2012.

Hospira, Inc. Customer Service:
1-877-946-7747

500 mcg/mL; 2 mL amp (NDC 0409-2266-02)

500 mcg/mL; 5 mL amp (NDC 0409-2266-05)

Material shortage (API).

Product 500 mcg/mL, 2 mL amp (NDC 0409-2266-02): next delivery May.

Product 500 mcg/mL; 5 mL amp (NDC 0409-2266-05): next delivery May.

Please check your wholesaler for all available inventory.

 

Amikacin Injection (updated 12/2/2011)

CompanyReasonRelated Information

Teva Pharmaceuticals
1-800-545-8800

Manufacturing delaysTeva has amikacin 250 mg/mL 4 mL vials available for drop shipment (NDC 00703-9040-03).
Bedford Customer Service
1-800-562-4797

250 mg/mL, 2 mL vials (NDC 55390-0226-02)
250 mg/mL, 4 mL vials (NDC 55390-0226-04)

Manufacturing delaysBedford has all amikacin presentations on back order and the company cannot estimate a release date.

 

Aminocaproic Acid  (updated 1/27/2012)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service: 1-877-946-7747

250 mg/mL; 20 mL vial
(NDC 0409-4345-73)

Other Manufacturer Shortage/Market Withdrawal

Product 250 mg/mL; 20 mL vial (NDC 0409-4346-73):  next delivery February.

Please check with your wholesaler for available inventory.

 


 
American Regent/Luitpold
631-924-4000		Manufacturing delaysAminocaproic Acid Injection, USP 250 mg/mL, 20 mL vial (NDC 00517-9120-25) has been released as of October 4, 2011.

 

Ammonium Chloride Injection (updated 10/31/2011)

Company/ProductsReasonRelated Information

Hospira, Inc.  Customer Service:
1-877-946-7747

5 mEq/mL; 20 mL vial

(NDC 0409-6043-01) 

Other manufacturer shortages/market withdrawal.

Product 5 mEq/mL; 20 mL vial (NDC 0409-6043-01):  company estimates a release date by June 2012.

Please check with your wholesaler for available inventory.

 

Ammonium molybdate injection  (5/19/2011)

Company/ProductsReasonRelated Information

American Regent/Luitpold

631-924-4000

American Regent Molybdenum 25 mcg/mL, 10 mL vial (NDC 00517-6610-25)

Manufacturing delaysAmerican Regent has ammonium molybdate injection on back order and the company cannot estimate a release date.

 

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (9/18/2008)

Company/ProductsReasonRelated Information

Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week.
phone

See information in Related Information section.

Limited supplies continue to be available.

Please see attached Dear Healthcare Professional Letter (PDF - 66KB) for important safety information.

 

Amphetamine Mixed Salts, ER Capsules  (updated 10/31/2011)

Company/ProductsReasonRelated Information
Shire Customer Service:
1-800-828-2088

Adderall XR capsules
5 mg - 100 count (NDC 54092-0381-01); 10 mg - 100 count (NDC 54092-0383-01); 15 mg - 100 count (NDC 54092-0385-01); 20 mg - 100 count (NDC 54092-0387-01); 25 mg - 100 count (NDC 54092-0389-01); 30 mg - 100 count (NDC 54092-0391-01)

API supply issues and uneven product distribution patterns.Product availability for all dosage strengths is adequate.
Teva Customer Service
(888)838-2872

5 mg - 100 count (NDC 00555-0790-02); 10 mg - 100 count (NDC 00555-0787-02); 15 mg - 100 count (NDC 00555-0791-02); 20 mg - 100 count (NDC 00555-0788-02); 25 mg - 100 count (NDC 00555-0792-02); 30 mg - 100 count (NDC 00555-0789-02)

API supply issuesTeva continue to release product as it becomes available.
Global Customer Service:
(215)558-4300

10 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01)

Inadequate finished product supply to support current market demandAll finished product strengths are currently available on an allocated basis.

 

Amphetamine Mixed Salts Immediate-Release Tablets (updated 1/12/2012)

Company/ProductsReasonRelated Information
Sandoz Customer Service:
1-609-627-8500

5 mg tablets, 100 count (NDC 00185-0084-01)

10 mg tablets, 100 count (NDC 00185-0111-01)

20 mg tablets, 100 count (NDC 00185-0401-01)

30 mg tablets, 100 count (NDC 00185-0404-01)

Increase in demandReleasing product as it becomes available.
CorePharma
1-800-850-2719

5 mg tablets, 100 count (NDC 64720-0130-10)

10 mg tablets, 100 count (NDC 64720-0132-10)

20 mg tablets, 100 count (NDC 64720-0135-10)

30 mg tablets, 100 count (NDC 64720-0136-10)

Increase in demandCorePharma is releasing product as it becomes available.
Teva Customer Service:
1-888-838-2872

5 mg tablets, 100 count (NDC 00555-0971-02)

7.5 mg tablets, 100 count (NDC 00555-0775-02)

10 mg tablets, 100 count (NDC 00555-0972-02)

12.5 mg tablets, 100 count (NDC 00555-0776-02)

15 mg tablets, 100 count (NDC 00555-0777-02)

20 mg tablets, 100 count (NDC 00555-0973-02)

30 mg tablets, 100 count (NDC 00555-0974-02)

Adderall, 5 mg tablets, 100 count (NDC 00555-0762-02)

7.5 mg tablets, 100 count (NDC 00555-0763-02)

10 mg tablets, 100 count (NDC 00555-0764-02)

12.5 mg tablets, 100 count (NDC 00555-0765-02)

15 mg tablets, 100 count (NDC 00555-0766-02)

20 mg tablets, 100 count (NDC 00555-0767-02)

30 mg tablets, 100 count (NDC 00555-0768-02)

API supply issuesTeva continue to release product as it becomes available.

 

Anadrol-50 tablets (Oxymetholone Tablets) (updated 12/21/2011)

Company/ProductsReasonRelated Information
Meda Pharmaceuticals Inc.:
732-564-2200

50 mg (bottles of 100) - NDC 68220-055-10

This shortage is due to Active Pharmaceutical Ingredient (API) constraints.Meda estimates that Anadrol may be available March 2012.

 

Aquasol A (updated 11/23/2011)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747

50,000 units/mL, 2 mL ampule (NDC 61703-418-07)

Change in manufacturing sites.Hospira anticipates next delivery in 2Q 2012.

 

Atracurium besylate (1/9/2012)

Company/ProductsReasonRelated Information
American Regent/Luitpold:
1-800-562-4797

10 mg/mL, 5 mL vial, single dose vial (NDC 55390-0102-05)

10 mL vial, multi-dose vial (NDC 55390-0103-10)

5 mL Novaplus vial, single dose vial (NDC 55390-0180-05)

10 mL Novaplus vial, multi-dose vial (NDC 55390-0179-10)

Manufacturing delaysAtracurium besylate is on back order with no estimated date of availability.

 

Atropine Sulfate Injection  (updated 1/25/2012)

Company/ProductsReasonRelated Information
Amphastar Pharmaceuticals Inc.
Customer Service:
1-800-423-4136

0.1 mg/mL, 10 mL, Luer-Jet Prefilled Syringe
(NDC 00548-339-00)

No current shortageN/A
Hospira, Inc.
Customer Service:
1-877-946-7747

0.1 mg/mL; 10 mL Ansyr syringe
(NDC 0409-1630-10)

0.05 mg/mL; 5 mL Ansyr syringe
(NDC 0409-9630-05)

0.1 mg/mL; 5 mL Lifeshield syringe
(NDC 0409-4910-34)

0.1 mg/mL; 10 mL Lifeshield syringe
(NDC 0409-4911-34)

Manufacturing delay

Product 0.1 mg/mL; 10 mL Ansyr syringe (NDC 0409-1630-10): ample levels of inventory to support market demand.
 
Product 0.05 mg/mL; 5 mL Ansyr syringe (NDC 0409-9630-05): next delivery March.
 
Product 0.1 mg/mL; 5 mL Lifeshield syringe (NDC 0409-4910-34): currently product is available.
 
Product 0.1 mg/mL; 10 mL Lifeshield syringe (NDC 0409-4911-34): currently product is available. Please check with your wholesaler for available inventory.

American Regent/Luitpold
631-924-4000

0.4 mg/mL, 0.5 mL ampule, package of 25
(NDC 00517-0805-25)

0.4 mg/mL, 1 mL single-dose vial, package of 25
(NDC 00517-0401-25)

1 mg/mL, 1 mL single-dose vial, package of 25
(NDC 00517-1010-25)

1 mg/mL, 1 mL ampule, package of 25 (NDC 00517-0101-25)

American Regent had temporarily suspended manufacture of most drug products in April, 2011No stock available. Anticipate to have lots available March 2012.
West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174
(Formerly a Baxter Product)

0.4 mg/mL, 20 mL vial
(NDC 10019-250-20)

Increase in product demand.

West-Ward is currently experiencing a backorder situation on the 0.4 mg/mL, 20 mL vial.

 

West-Ward has accelerated production on this product and is projecting to have several lots available by the end of December 2011.

 

Product will be made available as it is released

 

Avalide (irbesartan and hydrochlorothiazide)Tablets (3/25/2011)

Company/ProductsReasonRelated Information
Bristol-Myers Squibb
1-800-321-1335		Manufacturing delaysPlease see the following link for updated information: Bristol-Myers Squibdisclaimer icon

 

Bleomycin Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20)

Increased demandAPP has Bleomycin 15 units and 30 units presentations on back order.   Releases on both presentations are expected in early January 2012.
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva-Sicor has available bleomycin 15 unit (NDC 00703-3154-01) vials. They are reviewing orders prior to release.
Bedford
1-800-562-4797

15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01)

Product discontinuedBedford currently has all presentations discontinued.

Hospira Inc. Customer Service:
1-877-946-7747

15 unit vial (NDC 61703-0332-18)

 

30 unit vial (NDC 61703-0323-22)

Other Manufacturer Shortages/Market WithdrawalProduct 15 unit vial (NDC 61703-332-18):  next delivery February.
 
Product 30 unit vial (NDC 61703-323-22):  next delivery February.

Please check with your wholesaler for available inventory.

 

Bupivacaine Hydrochloride Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300		Increased demandAPP has Sensorcaine (with & without Epinephrine) on intermittent back-order and the company is releasing product as it becomes available.

Hospira, Inc.
Customer Service
1-877-946-7747

 

0.25%; 30 mL amp
(NDC 0409-1158-01)

0.25%; 10 mL vial
(NDC 0409-1159-01)

0.25%; 30 mL vial
(NDC 0409-1159-02)

0.25%; 50 mL vial
(NDC 0409-1160-01)

0.5%; 10 mL vial
(NDC 0409-1162-01)

0.5%; 30 mL vial
(NDC 0409-1162-02)

0.75%; 10 mL vial
(NDC 0409-1165-01)
 

0.75%; 30 mL vial
(NDC 0409-1165-02)

0.25% w/epi 1:200,000; 10 mL vial
(NDC 0409-9042-01)

0.25% w/epi 1:200,000; 30 mL vial
(NDC 0409-9042-17)

0.25% w/epi 1:200,000; 50 mL
(NDC 0409-9043-01)

0.5% w/epi 1:200,000; 10 mL vial
(NDC 0409-9045-01)

0.5% w/epi 1:200,000; 30 mL vial
(NDC 0409-9045-17)

0.5% w/epi 1:200,000; 50 mL vial
(NDC 0409-9046-01)

 

50 mg/20 mL Sterile pack amp

(NDC 0409-4272-01)

Manufacturing delaysProduct 0.25%; 30 mL amp (NDC 0409-1158-01): next delivery April.

Product 0.25%; 10 mL vial (NDC 0409-1159-01): next delivery February.

Product 0.25%; 30 mL vial (NDC 0409-1159-02): next delivery February.

Product 0.25%; 50 mL vial (NDC 0409-1160-01): next delivery February.

Product 0.5%; 10 mL vial (NDC 0409-1162-01): next delivery February.

Product 0.5%; 30 mL vial (NDC 0409-1162-02):  next delivery February.
 
Product 0.5%; 50 mL vial (NDC 0409-1163-01):  next delivery February.
 
Product 0.75%; 10 mL vial (NDC 0409-1165-01): next delivery February.
 
Product 0.75%; 30 mL vial (NDC 0409-1165-02): next delivery February.

Product 0.25% w/epi 1:200,000; 10 mL vial (NDC 0409-9042-01): next delivery April.

Product 0.25% w/epi 1:200,000; 30 mL vial (NDC 0409-9042-17): ample levels of inventory to support market demand.

Product 0.25% w/epi 1:200,000; 50 mL vial (NDC 0409-9043-01): next delivery February.
 
Product 0.5% w/epi 1:200,000; 10 mL vial (NDC 0409-9045-01): next delivery April.

Product 0.5% w/epi 1:200,000; 30 mL vial (NDC 0409-9045-17): next delivery February..

Product 0.5% w/epi 1:200,000; 50 mL vial (NDC 0409-9046-01): next delivery February.
 
Product 50 mg/20 mL Sterile pack amp (NDC 0409-4272-01)  next delivery March.
 
Product 0.25%; 20 mL amp (NDC 0409-5622-01):  next delivery February.
 
Product 0.5%; 20 mL Sterile pack amp (NDC 0409-4273-01):  next delivery March.
 
Please check with your wholesaler for available inventory.

 

Buprenorphine Injection  (updated 12/2/2011)

Company/ProductsReasonRelated Information
Bedford
1-800-562-4797

1 mL vial (NDC 55390-0010-10)

DelaysBedford has buprenorphine injection on back order and the company cannot estimate a release date.
Hospira
1-877-946-7747

1 mL Carpuject syringe (NDC 00409-2012-32

API supply constraints; require FDA approval of a new API supplierHospira is working through FDA to gain approval of the new API supplier in order to resume production.
American Regent
1-800-645-1706

1 mL vial (NDC 00517-0725-05)

DelaysAmerican Regent has buprenorphine injection 0.3 mg/mL 1 mL vials on long term back order and the company cannot estimate a release date.
Reckitt Benckiser
804-379-1090

Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01)

Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01) are availableReckitt Benckiser has Buprenex 0.3 mg/mL 1 mL ampules (NDC 12496-0757-01) available.

 

Butorphanol Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information

Hospira, Inc.
Customer Service:
1-877-946-7747

  

1 mg/mL; 1 mL vial

(NDC 0409-1623-01)


2 mg/mL; 1 mL vial

(NDC 0409-1626-01)


2 mg/mL; 2 mL vial

(NDC 0409-1626-02)

Other manufacturer shortage/market withdrawal.Product 1 mg/mL; 1 mL vial (NDC 0409-1623-01): next delivery March.
 
Product 2 mg/mL; 1 mL vial (NDC 0409-1626-01): next delivery February.
Product 2 mg/mL; 2 mL vial (NDC 0409-1626-02: next delivery March.
 
Please check with your wholesaler for all available inventory.
Bedford Customer Service:
1-800-562-4797

1 mg/mL 1 mL vial (NDC 55390-0183-01)
1 mg/mL 1 mL Novaplus vial (NDC 55390-0341-10)
2 mg/mL 1 mL vial (NDC 55390-0184-01)
2 mg/mL 2 mL vial (NDC 55390-0184-02)
2 mg/mL 1 mL Novaplus vial (NDC 55390-0342-10)
2 mg/mL 10 mL vial (NDC 55390-0185-10)

Manufacturing delaysBedford has all butorphanol presentations on back order and the company cannot estimate a release date.

 

Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL)  (11/23/2011)

Company/ProductsReasonRelated Information
American Regent/Luitpold:
631-924-4000

American Regent 2 mL single-dose vial, package of 10 (NDC 00517-2502-10)

Manufacturing delaysAmerican Regent has caffeine and sodium benzoate injection on back order and the company cannot estimate a release date.

 

Calcitriol 1 mcg/mL Injection  (updated 1/31/2012)

Company/ProductsReasonRelated Information
American Regent, Inc.
1-800-645-1706

1 mL ampule, 25 count (NDC 00517-0132-25)

Increased demandAmerican Regent has calcitriol injection on back order and the company cannot estimate a release date.
APP Pharmaceuticals
1-888-386-1300

1 mcg/ml; 1 mL ampule, 50 count (NDC 63323-0731-01

AvailableAPP has Calcitriol injection available.
West-Ward Pharmaceuticals Customer Service:
1-800-631-2174

1 mL ampule, 5 count (NDC 00143-9728-05)

Contract manufacturer cannot meet USP requirementsWest-Ward has calcitriol injection on back order and the company cannot estimate a release date.
Akorn Pharmaceuticals
1-800-932-5676

Akorn 1 mL ampule, 10-pack (NDC 17478-0931-01)

n/aAkorn has calcitriol 1 mcg/mL 1 mL ampules in 10-packs available to order.

 

Calcium Chloride Injection (updated 1/25/2012)

Company/ProductsReasonRelated Information

Hospira Inc.
1-877-946-7747

 

100 mg/mL; 10 mL Abboject

(NDC 0409-4928-34)

 

100 mg/mL; 10 mL Ansyr

(NDC 0409-1631-10)

Manufacturing delay

Product 100 mg/mL; 10 mL Abboject (NDC 0409-4928-34):  next delivery February.

 

Product 100 mg/mL; 10 mL Ansyr (NDC 0409-1631-10):  next delivery February.

 

Please check with your wholesaler for available inventory. 

American Regent, Inc.
1-800-645-1706		 American Regent, Inc. is currently releasing Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial.
Amphastar Pharmaceuticals, Inc./IMS
1--800-423-4136		 Amphastar (IMS) in cooperation with FDA will re-introduce its emergency syringes including Dextrose 50%, Epinephrine 0.1mg/mL, Calcium Chloride 100mg/mL, Sodium Bicarbonate 8.4%, Atropine Sulfate 0.1mg/mL, Lidocaine 2%, and Morphine 1mg/mL. Calcium Chloride 100mg/ml syringes (NDC 0548-3304-00/product code 3304) were released by Amphastar/IMS on 9/7/10 and are now available.

 

Calcium Gluconate (updated 1/30/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

100 mg/mL vials, 10 mL vials (NDC 63323-0311-10)50 mL vials (NDC 63323-0311-50) 100 mL vials (NDC 63323-0311-61)

Increased DemandAPP has calcium gluconate 100 mg/mL - 100 mL (63323-311-61) & 100mg/mL- 50 mL (63323-311-50) vials on intermittent back order due to increased demand and the company is releasing the product as it becomes available. The 100 mg/mL- 10mL (63323-311-10) vials are being allocated.  The 200 mL vials have been discontinued.
American Regent, Inc.
1-800-645-1706

50 mL (NDC 005173950-25)

100 mL NDC (00517-3900-25) vials

 American Regent, Inc. is currently releasing Calcium Gluconate 100 mg/mL 50 mL and 100 mL vials. The 10 mL vial has been discontinued.

 

Cerezyme (imiglucerase for injection) (9/16/2011)

 

Chromic Chloride Injection (updated 1/13/2012)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service
1-877-946-7747

4 mcg/mL; 10 mL vial
(NDC 0409-4093-01)

Other manufacturer shortage/market withdrawal.

Product 4 mcg/mL; 10 mL vial (NDC 0409-4093-01):  next delivery April.

American Regent/Luitpold 631-924-4000

SOL 4 mcg/ml INTRAVENOUS 10 ml 25s (NDC 00517-6310-25)

Manufacturing delaysAmerican Regent product is on back order with no estimated date of availability.

 

Cisplatin injection 1 mg/mL solution (updated 1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300
 
1 mg/ml; 50 mL vial (NDC 63323-0103-51)
 
1 mg/ml; 100 mL vial (NDC 63323-0103-65)
 
1 mg/ml; 200 mL vial (NDC 63323-0103-64)		Increased DemandAPP is continuing to allocate as releases occur.
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva continues to release cisplatin injection 1 mg/mL solution. 50 mL vial (NDC 00703-5747-11) and 100 mL vial (NDC 00703-5748-11) as it becomes available.
Bedford
1-800-562-4797		Product discontinuedBedford currently has all presentations discontinued.

 

Cocaine Topical Solution New!(2/1/2012)

Company/ProductsReasonRelated Information

Lannett
Customer Service:
1-215-333-9000

40 mg/mL; 4  mL vial (NDC 00527-1728-74)

10 mg/ml; 10 mL vial (NDC 00527-1728-73)
100 mg/mL; 4 mL vial (NDC 00527-1729-74)

100 mg/ml; 10 mL vial (NDC 00527-1729-73

No reason provided

40 mg/ml, 10ml vial (NDC 00527-1728-73) is available.

40mg/ml, 4ml vials are on back order and the company estimates a release date in early-February.

Lannett has discontinued the 100 mg/mL, 10 mL vial 10 mL vial (NDC 00527-1729-73) and temporarily discontinued 100 mg/ml, 4ml vials and the company cannot estimated when product will be available again.

 

Cosyntropin Injection (12/21/2011)

Company/ProductsReasonRelated Information
Mylan Institutional
1-888-258-4199

0.25mg/ml (NDC 10139-0905-02); packages of 10 (NDC 10139-0905-10)

Manufacturing delaysAnticipates availability in mid-late January.
Sandoz Customer Service:
1-609-627-8500

0.25mg/ml (NDC 00871-23052-71); Package of 10 (NDC 00781-3052-95)

Information pendingInformation pending

 

Cyanocobalamin injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
APP Pharmaceuticals
1-888-386-1300

1000 mcg/mL, 1 mL vial (NDC 63323-0044-01)

AvailableAPP has cyanocobalamin injection available.
American Regent, Inc.
1-800-645-1706

1000 mcg/mL, 1 mL vial (NDC 00517-0031-25), 1000 mcg/mL, 10 mL vial (NDC 00517-0032-25) 1000 mcg/mL, 30 mL vial (NDC 00517-0130-05)

Manufacturing delaysAmerican Regent has 1ml and 10 ml vials being released the week of September 26th.

 

Daunorubicin hydrochloride solution for injection  (updated 12/2/2011)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800

5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13)

Manufacturing issuesTeva has daunorubicin solution for injection on back order and estimates a release date of August, 2011.
Bedford Customer Service
1-800-562-4797

5 mg/mL, 4 mL single-dose vial (NDC 55390-0108-10), 10 mL single-dose vial (NDC 55390-0108-01) Cerubidine lyophilized powder for injection, 20 mg single-dose vial, package of 10 (NDC 55390-0281-10)

Manufacturing delaysBedford has all daunorbucin presentations on back order and the company cannot estimate a release date.

 

Desmopressin Injection (updated 1/25/2012)

Company/ProductsReasonRelated Information
Ferring
1 888 Ferring
(1-888-337-7464)

4 mcg/mL 1ml vials (NDC 55566-5030-01) and 4mcg/mL 10ml (NDC 55566-5040-01)

Manufacturing delay.

Product 4 mcg/mL; 1 mL amp (NDC 0409-2265-01):  next delivery March.

Please check with your wholesaler for available inventory.

Hospira Inc. Customer Service:
1-877-946-7747

4 mcg/mL, 1 mL amp (NDC 00409-2265-01)

Manufacturing delay

Product 4 mcg/mL; 1 mL amp (NDC 0409-2265-01):  next delivery March 2012.

Please check with your wholesaler for available inventory.

 

 

Sanofi-Aventis
1-800-981-2491

(DDAVP 4 mcg/mL 1 mL (NDC 00075-2451-01) and 10 mL (NDC 00075-2451-53))

Unanticipated increased demand

Desmopressin 4 mcg/mL, 1 mL (NDC 00075245101) ampule is available.

 

Desmopressin 4 mcg/mL,10 mL (NDC00075245153) vials will be available in Mid December.

Teva Pharmaceuticals
1-800-545-8800

(4 mcg/mL, 1 mL vial, 10 count (NDC 00703-5051-03) 10 mL multi-dose vial (NDC 00703-5054-01)).

Manufacturing delaysTeva has available desmopressin 4 mcg/mL 1 mL (NDC 00703-5051-03) and 10 mL (NDC 00703-5054-01) vials and is reviewing orders prior to release.

 

Dexamethasone Injection (updated 11/15/2011)

Company/ProductsReasonRelated Information
American Regent Inc.
(1-800-645-1706)		Manufacturing issuesAmerican Regent has recalled a number of their dexamethasone 4 mg/mL presentations due to the presence of particulate matter. The firm has placed their product on hold with no estimated release date.
APP
(1-888-386-1300)		APP has dexamethasone injection on allocation due to increased demand for the product.APP has Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 1 mL SDV (NDC 63323-165-01), 4 mg/mL, 5 mL SDV (NDC 63323-165-05), 4 mg/mL, 30 mL MDV (NDC 63323-165-30), 10 mg/mL, 1 mL SDV (NDC 63323-506-01),  10 mg/mL, 10 mL MDV (NDC 63323-516-10) presentations available.
West-Ward Pharmaceuticals
Customer Service:
1-888-229-0001
(Formerly a Baxter Product)

1 mL vial
(NDC 0641-0367-25)

Unexpected increase in product demand due to market supply issues.West-Ward is currently experiencing a backorder situation on the 10 mg/mL, 1 mL vial  (NDC 0641-0367-25). West-Ward has accelerated production and will have product available by the middle of July.  Additional lots are scheduled to be released by the end of August.

 

Dexrazoxane Injection (1/26/2012)

Company/ProductsReasonRelated Information
Mylan Institutional
1-888-258-4199

Dexrazoxane for injection
250 mg and 500mg

250 mg vial (NDC 67457-0207-25)

500 mg vial (NDC 67457-208-50)

Increased demandExpected release in mid 2012.
Pfizer Injectables
1-800-533-4535

http://www.pfizerinjectables.com/disclaimer icon

Pfizer has product available for both strengths.Pfizer Injectables has available vials of 250 mg NDC (0013-8717-62), 500 mg (NDC 0013-8727-89).
Topotarget USA, Inc.
1-973-895-6900

Totect 500 mg (dexrazoxane) for injection
(NDC 38423-110-01)

Manufacturing Delays

Limited supplies available at Cardinal, McKesson Specialty and Morris & Dickson each have 2 kits a piece (total 6 kits). Please check with these wholesalers directly for available inventory. Out of stock at ICS, ASD Healthcare, Oncology Supply and US Oncology.

Topotarget USA, Inc. has product on back order and the company cannot estimate a release

 

Dextroamphetamine Tablets (1/12/2012)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800

5 mg tablets, 100 count (NDC 00555-0952-02)
10 mg tablets, 100 count (NDC 00555-0953-02)

Manufacturing delaysTeva has dextroamphetamine 5 mg and 10 mg, 100 count tablets, will be on intermittent back order through mid-2012. Product will be released as it becomes available.

 

Diazepam Injection (updated 12/30/2011)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service:
1-877-946-7747

5 mg/mL; 2 mL Carpuject (0409-1273-32)

5 mg/mL; 10 mL vial
(0409-3213-12)

Carpuject: Material shortage.

Vial: Manufacturing delay.

Product 5 mg/mL; 2 mL Carpuject (0409-1273-32): next delivery February 2012.

 

Product 5 mg/mL; 10 mL vial (0409-3213-12): next delivery April 2012.

 

Digoxin Injection (updated 6/24/2011)

Company/ProductsReasonRelated Information
West-Ward Pharmaceuticals Customer Service:
1-888-229-0001 (Formerly a Baxter Product)

USP 250 mcg/mL, 2 mL ampuls (NDC 0641-1410-35)

Increase in product demandWest-Ward is currently experiencing a back order situation on the 2 mL ampuls (NDC 0641-1410-35) due to unforeseen demand driven by competitors' supply issues.  West-Ward has accelerated production and will have product available by the end of July – beginning of August.
Sandoz Customer Service:
1-609-627-8500

USP 250 mcg/mL, 2 mL (NDC 0781-3059-95)

Manufacturing delaysSandoz anticipates supply in 3Q 2011.
GlaxoSmithKline Customer Service:
888-825-5249

Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35)

Manufacturing delaysGSK has discontinued the manufacturing Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35)

250 mcg/mL, 2 mL (10s - NDC 00173-0260-10) is currently on back-order and should be available January 2012.

 

Diltiazem Injection (updated 1/23/2012)

Company/ProductsReasonRelated Information

West-Ward Pharmaceuticals Customer Service
1-888-229-0001

(Formerly a Baxter Product)

5 mL vial (NDC 10019-510-01) 10 mL vial (NDC 10019-510-02)

25 mL vial (NDC 10019-510-04)

Increase in product demandWest-Ward is experiencing a back order situation on all codes and estimates the following product availability:

5 mL vial (NDC 10019-510-01) Additional product releases expected later this month and at the end of May.

10 mL vial (NDC 10019-510-02) - Product will be available end of May

25 mL vial (NDC 10019-510-04) - Product releases expected by mid April and end of May.

Product will be made available as it is released.

Hospira Customer Service
(1-877-946-7747)

5 mg/mL, 5 mL vials

(NDC 00409-1171-01)

 

5 mg/mL, 10 mL vials

(NDC 00409-1171-02)

100 mg/mL, ADD-Vantage vials (NDC 00409-4350-03)

Higher than anticipated market demand.

 

Product 5 mg/mL; 5 mL vial (NDC 0409-1171-01):  next deliver February.
 
Product 100 mg/mL; ADD-Vantage vial (NDC 0409-4350-03):  ample levels of inventory to support market demand.
 
Product 5 mg/mL; 10 mL vial (NDC 0409-1171-02):  ample levels of inventory to support market demand.

Please check with your wholesaler for available inventory. 

Bedford Customer Service
1-800-562-4797

5 mg/mL 5 mL vials (NDC 55390-0565-05), 5 mg/mL 10 mL vials (NDC 55390-0565-10)

5 mg/mL 25 mL vials (NDC 55390-0565-30), 5 mg/mL 5 mL Novaplus vials (NDC 55390-0566-05)

5 mg/mL 10 mL Novaplus vials (NDC 55390-0566-10), 5 mg/mL 25 mL Novaplus vials (NDC 55390-0566-30)

Manufacturing delaysBedford has all diltiazem presentations  on back order and the company cannot estimate a release date.
Akorn Pharmaceuticals
1-800-932-5676

5 mg/mL, 25 mL vials (NDC 17478-0937-25)

N/AAkorn has product available.

 

Diphenhydramine Hydrochloride Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

50 mg/ml, 1 ml (NDC 63323-0664-01)

Increased in demandAPP is releasing product as it becomes available. Please check wholesalers for inventory.
Hospira Customer Service
1-877-946-7747

50 mg/mL; 1 mL Carpuject (NDC 0409-2290-31)

Manufacturing delays

Product 50 mg/mL; 1 mL Carpuject (NDC 0409-2290-31): next delivery June 2012.

Mylan Institutional
1-888-258-4199

50 mg/ml, 10 ml, 10s
(NDC 67457-0124-10)

Increased demandMylan has increased production in an effort to keep up with current demand.
West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174
(Formerly a Baxter Product)

50 mg/mL, 1 mL vial
(NDC 0641-0376-25)

Increased demand

West-Ward is currently experiencing a backorder situation on the 50 mg/mL, 1 mL vial.

West-Ward has accelerated production on this product and is projecting to have several lots available by the middle of December 2011.

Product will be made available as it is released.

 

Doxorubicin (adriamycin) lyophilized powder (updated 12/2/2011)

Company/ProductsReasonRelated Information
Bedford

10 mg vials (NDC 55390-0231-01)

20 mg vials (NDC 55390-0232-10)

50 mg vial (NDC 55390-0233-01)

Manufacturing delaysBedford has all doxorubicin lyophilized presentations on back order and the company cannot estimate a release date.

 

Doxorubicin Liposomal (Doxil) Injection (updated 1/13/2012)

 

Doxorubicin Solution for Injection (updated 12/16/2011)

Company/ProductsReasonRelated Information
APP
1-888-386-1300
APP Product Availability Informationdisclaimer icon		Increased demandAPP has available the 2 mg/mL 5 mL vials (NDC 63323-883-05), the 2 mg/mL 10 mL vials (NDC 63323-883-10), the 2 mg/mL 25 mL vials (NDC 63323-0883-30), and the 2 mg/mL 100 mL vials (NDC 63323-0101-61).
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva plans to have doxorubicin solution for injection, 2 mg/mL 5 mL vial (NDC 00703-5043-03) 25 mL vial (NDC 00703-5046-01) 100 mL vial (NDC 00703-5040-01) available again in early 2012.
Bedford
1-800-562-4797		Manufacturing delaysBedford has  all doxorubicin solution presentations on backorder and the company cannot estimate a release date.
Pfizer Injectables
1-800-533-4535
http://www.pfizerinjectables.com/disclaimer icon		Pfizer has product availablePfizer Injectables has available vials of 10mg/5mL (NDC 0069-3030-20), 20mg/10mL (NDC 0069-3031-20), 50mg/25mL (NDC 0069-3032-20), 150mg/75mL (NDC 0069-3033-20), 200mg/100mL (NDC 0069-3034-20).

 

Ethiodol (ETHIODIZED OIL) ampules (12/10/2010)

Company/ProductsReasonRelated Information
Guerbet LLC
Customer Service
(1-877-729-6679)		Product has been discontinued by Nycomed US Inc.Guerbet has acquired the Ethiodol NDA from Nycomed US Inc. effective May 7, 2010 and is working with FDA to resume manufacturing of Ethiodol in the near future to ensure continued availability for the US patients. During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ULTRA-FLUIDE, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market.

See Dear Healthcare Professional Letter (PDF - 588KB) for additional information.
(Letter updated 12/10/2010)

 

Etoposide solution for injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
Bedford
1-800-562-4797		Increased demandBedford has all  etoposide presentations  on back order and the company cannot estimate a release date.
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva has Toposar 20 mg/mL solution for injection 5 mL (NDC 00703-5653-01)   25 mL and 50 mL vials on back order - Teva is working on having additional supplies as soon as possible.

APP
1-888-386-1300
 
20 mg/mL; 5 mL vial (NDC 63323-0104-05)


20 mg/ml; 25 mL vial (NDC 63323-0104-25)


20 mg/ml;50 mL vial (NDC 63323-0104-50) 

Increased demandAPP is allocating all etoposide 20 mg/mL 5 mL and 25 mL vials. 50 mL vials are on back order with an estimated release date of late-February, 2012.
BMS Customer Service
1-800-426-7644		Increased demandBMS has available Etopophos 100 mg powder for injection (NDC 00015-3404-20).
Accord Healthcare
919-941-7879

100mg/5mL, 5mL vial (NDC#16729-114-31)

Increase in demandAccord will have limited products available beginning February.

 

Fabrazyme (agalsidase beta) (updated 1/24/2012)

Company/ProductsReasonRelated Information
Genzyme Corporation

For inquiries contact Genzyme Medical Information: This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 800-745-4447, option 2

Manufacturing delaysVisit Web site: Genzyme supply updatedisclaimer icon

 

Fentanyl Citrate Injection  (updated 1/27/2012)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service:
1-877-946-7747

0.05 mg/mL; 2 mL Carpuject
(0409-1276-32)

0.05 mg/mL; 2 mL amp
(0409-9093-32)

0.05 mg/mL; 5 mL amp
(0409-9093-35)

0.05 mg/mL; 20 mL amp
(0409-9093-38)

0.05 mg/mL; 2 mL vial
(0409-9094-22)

0.05 mg/mL; 5 mL vial
(0409-9094-25)

0.05 mg/mL; 10 mL vial
(0409-9094-28)

0.05 mg/mL; 20 mL vial
(0409-9094-31)

0.05 mg/mL; 50 mL vial
(0409-9094-61)

Manufacturing delayProduct 0.05 mg/mL; 2 mL amp (0409-9093-32):  next anticipated delivery April.

Product 0.05 mg/mL; 5 mL amp (0409-9093-35):  next anticipated delivery February.

Product 0.05 mg/mL; 20 mL amp (0409-9093-38):  next anticipated delivery February.

Product 0.05 mg/mL; 2 mL vial (0409-9094-22):  next anticipated delivery May.

Product 0.05 mg/mL; 5 mL vial (0409-9094-25):  next anticipated delivery May.

Product 0.05 mg/mL; 10 mL vial (0409-9094-28):  next anticipated delivery May.

Product 0.05 mg/mL; 20 mL vial (0409-9094-31):  next anticipated delivery May.

Product 0.05 mg/mL; 50 mL vial (0409-9094-61):  next anticipated delivery May.

Fentanyl products listed above must be ordered through the wholesaler; check with your wholesaler regarding product allocation.  It is recommended that the user institute fentanyl sparing strategies.
 
________
 
Product 0.05 mg/mL; 2 mL Carpuject (0409-1276-32):  next delivery February.
 
Carpuject orders (NDC 0409-1276-32) may be placed direct or through the wholesaler, and will be filled in the order in which received.

West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174
(Formerly a Baxter Product)

50 mcg/mL

2 mL ampul
(NDC 10019-038-67)

5 mL ampul
(NDC 10019-033-72)

20 mL ampul
(NDC 10019-035-74)

2 mL vial
(NDC 10019-037-27)

5 mL vial
(NDC 10019-037-30)

20 mL vial
(NDC 10019-037-25)

50 mL vial
(NDC 10019-037-83)

Increase in product demand

West-Ward is currently experiencing a backorder situation on all presentations due to unforeseen demand driven by competitor supply issues. West-Ward has accelerated production and will have the following products available.

Lots of the 2 mL, 5 mL, and 20 mL ampul products will be released and available in November 2011.

Additional lots of the 2 mL, 5 mL, 20 mL, and 50 mL vials are scheduled to be manufactured and available in the November – December 2011 timeframe.

Product will be made available as it is released.

 

Fluorouracil Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
Mylan Institutional
1-888-258-4199		Increased demandMylan Institutional (formerly Bioniche Pharma) has fluorouracil injection 50 mg/mL vials on intermittent back order and the company is releasing allocated product as it becomes available. It is only available for drop shipment orders through wholesalers at this time.
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva has all fluorouracil injection presentations on back order and the company estimates a release date of 4th quarter, 2011.

APP
1-888-386-1300

 

50 mg/ml; 10 mL vial (NDC 63323-0117-10)
50 mg/ml; 20 mL vial (NDC 63323-0117-20)
 
50 mg/mL; 50 mL vial (NDC 63323-0117-51)
50 mg/mL; 100 mL vial (NDC 63323-0117-61)

Increased demandAPP has Fluorouracil injection on allocation but product is readily available. Check with wholesalers for inventory.

 

Foscarnet Sodium Injection (updated 9/16/2011)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service
1-877-946-7747

24 mg/mL; 250 mL bottle
(NDC 0409-3863-02)

24 mg/mL; 500 mL bottle
(NDC 0409-3863-05)

Manufacturing delaysHospira is working to resolve the manufacturng delay and additional information on availability will be forthcoming.
Clinigen Healthcare Please see attached Dear Healthcare Professional Letter (PDF - 519KB) for updated information regarding distribution.

 

Fosphenytoin Sodium Injection (updated 11/15/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
1-800-562-4797		Not currently marketedProduct Discontinued: Bedford currently has all presentations discontinued.
Hospira
Customer Service:
1-877-946-7747

75 mg/mL; 2 mL vial
(NDC 0409-4857-02)

75 mg/mL; 50 mL vial
(NDC 0409-4857-10)

Manufacturing delayBoth presentations are temporarily discontinued.
Akorn Pharmaceuticals
1-800-932-5676		Not currently marketedAkorn will be off the market for an period of time.
APP
1-888-386-1300		Increase in demandAPP has all presentations available.
West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174		Increase in demandWest-Ward has available NDC# 0143-9788-25 fosphenytoin 150 mg/2ml and NDC# 0143-9782-10 fosphenytoin 750 mg/10 ml.
American Regent, Inc.
1-800-645-1706		Newly launched productAmerican Regent reports availability of fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25).

 

Furosemide Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

10 mg/mL; 4 mL Ansyr syringe
(NDC 0409-9631-04)

10 mg/mL; 10 mL Ansyr syringe
(NDC 0409-1639-10)

10 mg/mL; 2 mL vial
(NDC 0409-6102-02 )

10 mg/mL; 4 mL vial
(NDC 0409-6102-04)

10 mg/mL; 10 mL vial
(NDC 0409-6102-10)

Manufacturing delay

Product 10 mg/mL; 10 mL Ansyr syringe (NDC 0409-1639-10):  next delivery March.

 

Product 10 mg/mL; 4 mL vial (NDC 0409-6102-04):  next delivery February.

 

 

Other presentations:  Product available.

 

 

American Regent, Inc.
1-800-645-1706		Increase in demandAmerican Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end use.

APP
1-888-386-1300

 

10 mg/mL; 2 mL (NDC 63323-0280-02)
10 mg/ml; 4 mL (NDC 63323-0280-04)
10 mg/mL; 10 mL vial (NDC 63323-0280-10)

N/AAPP has furosemide 10mg/ml 2 mL vials (NDC 63323-0280-02), 4 mL vials (NDC 63323-0280-04), and 10 mL vials (NDC 63323-0280-10) available.

 

Haloperidol Decanoate Injection (updated 12/15/2011)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva has all presentations on back order.
Ortho-McNeil Janssen
1-800-526-7736		See Related InformationOrtho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14).
APP Pharmaceuticals
1-888-386-1300		See Related InformationAPP has available Haloperidol Decanoate  50mg/mL, 5 mL vials (NDC 63323-0469-05), and  and 100mg/mL, 5 mL (NDC 63323-0471-05) vials. The 100 mg/mL 1 mL (NDC 63323-0471-01) &  50 mg/mL 1 mL (NDC 63323-0469-01) presentations are on backorder and the company is releasing product as it becomes available.
Bedford Laboratories
Customer Service
1-800-562-4797		Product discontinuedBedford has all presentations of the Haloperidol Decanoate discontinued.

Patriot Pharmaceuticals, LLC.
1-800-631-5273

50 mg/mL Injection, 1 mL Ampules (NDC: 10147-0921-3)

 

100 mg/mL Injection, 1 mL Ampules (NDC: 10147-0922-5)

N/APatriot Pharmaceuticals has product available for ordering.

 

Indigo Carmine Injection (updated 1/24/2011)

Company/ProductsReasonRelated Information
Akorn Pharmaceuticals
1-800-932-5676

8 mg/mL, 5 mL ampule
(NDC 17478-0508-01)

Increase in demand

Akorn has Indigo Carmine available.

American Regent, Inc.
1-800-645-1706

8 mg/mL, 5 mL ampule
(NDC 00517-0375-10)

Manufacturing delaysAmerican Regent has indigo carmine on back order and the company cannot estimate a release date.

 

Insulin glulisine [rDNA origin] injection) solution for injection (Apidra SoloStar)
 (10/19/2011)

Company/ProductsReasonRelated Information
Sanofi-Aventis
1-800-981-2491		Manufacturing delaysProduct to be available 1st quarter 2012. Please note Apidra vials are not impacted by this shortage.

Dear Healthcare Professional Letter (PDF - 33KB)

 

Intravenous Fat Emulsion (updated 6/3/2011)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

Liposyn III (fatemulsion/soybean oil)

10%; 250 mL (NDC 0409-9790-02)

10%; 500 mL (NDC 0409-9790-03)

20%; 250 mL (NDC 0409-9791-02)

20%; 500 mL (NDC 0409-9791-03)

30%; 500 mL (NDC 0409-6892-03)

Manufacturing delayProducts 10%; 250 mL (NDC 0409-9790-02), 10%; 500 mL (NDC 0409-9790-03), 20%; 250 mL (NDC 00409-9791-02), 20%; 500 mL (NDC 00409-9791-03) and 30%; 500 mL (NDC 00409-6892-03):  Hospira is working with FDA to address the issues that led to the shortage.
Baxter (Intralipid Emulsion)
Customer Service:
(1-888-229-0001)		Baxter now has adequate supply available to meet demand.Baxter has the following Intralipid emulsions available through normal distribution:
20% 100 mL (NDC 00338-0519-48) 20% 250 mL (NDC 00338-0519-02) 20% 500 mL (NDC 00338-0519-03) 20% 1000 mL (NDC 00338-0519-04) 30% 500 mL (NDC 00338-0520-03)

 

Isoniazid Tablets (updated 11/23/2011)

Company/ProductsReasonRelated Information
West-Ward Pharmaceuticals
Customer Service:
1-888-229-0001

(300 mg - 30s - 00143-1261-30, 100s - 00143-1261-01, 1000s - 00143-1261-10; 100mg - 100s - 00143-1260-01, 1000s - 00143-1260-10)

Increase demandReleases planned for September and November
Teva Customer Service:
(888)838-2872

(300 mg - 30s - 00555-0071-01, 100s - 00555-0071-02, 1000s - 00555-0071-05; 100mg - 100s - 00555-0066-02, 1000s - 00555-0066-05)

Delayed releaseReleases planned for September for 300 mg product, 100 mg product continues to be in supply.
Sandoz Customer Service:
1-609-627-8500

(300 mg - 30s - 00185-4350-30, 100s - 00185-4350-01, 1000s - 00185-4350-10; 100mg - 30s - 00185-4351-30, 100s - 00185-4351-01, 1000s - 00185-4351-10)

API supply issues

100 mg product currently available

300 mg product available around july 2012

VersaPharm Service:
1-800-548-0700

(300 mg - 30s - 61748-0013-30, 100s - 61748-0013-01, 1000s - 61748-0013-10; 100mg - 100s - 61748-0016-01)

 Information pending
 

 

Ketorolac Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information

Bedford Customer Service
1-800-562-4797

15 mg/mL 1 mL vial, 10 count (NDC 55390-0480-01)

 

30 mg/mL 1 mL vial, 10 count (NDC 55390-0481-01)

 

30 mg/mL 10 mL vial, 10 count (NDC 55390-0481-10)

Manufacturing delays

Bedford has all presentations of ketorolac injection on back order and the company cannot estimate a release date

American Regent/Luitpold
631-924-4000

 

15 mg/mL 1 mL vial, 25 count (NDC 00517-0601-25)

 

30 mg/mL 1 mL vial, 25 count (NDC 00517-0801-25)

 

30 mg/mL 2 mL vial for intramuscular use, 25 count (NDC 00517-0902-25)

 American Regent/Luitpold is currently not manufacturing Ketorolac Tromethamine Injection, USP

Wockhardt

30 mg/mL 1 mL vial, 10 count (NDC 64679-0758-04)

 

30 mg/mL 2 mL vial, 10 count (NDC 64679-0758-06)

 

30 mg/mL 2 mL vial, 25 count (NDC 64679-0758-02)

Increase in demandWockhardt has ketorolac 30 mg/mL 2 mL vials in 10 count and 25 count presentations on back order with an estimated release date of late-January, 2012. The 30 mg/mL 1 mL vial 10 count presentation is on back order and the company cannot estimate a release date.

APP
1-888-386-1300

 

15 mg/mL 1 mL vial, 25 count (NDC 63323-0161-01)

 

30 mg/mL 1 mL vial, 25 count (NDC 63323-0162-01)

 

30 mg/mL 2 mL vial for intramuscular injection, 25 count (NDC 63323-0162-02)

Raw material supplyAPP has all presentations of ketorolac injection on back order and the company cannot estimate a release date.

Hospira, Inc.
Customer Service
1-877-946-7747

15 mg/mL; 1 mL vial
(NDC 0409-3793-01)

15 mg/mL; 1 mL Carpuject
(NDC 0409-2288-31)

30 mg/mL; 1mL vial
(NDC 0409-3795-01)

30 mg/mL; 1 mL Carpuject
(NDC 0409-2287-31)

30 mg/mL; 2 mL Carpuject
(NDC 0409-2287-61)

60 mg/mL; 2 ml vial
(NDC 0409-3796-01)

Higher than anticipated market demand; Manufacturing delay.

Product 15 mg/mL; 1 mL vial (NDC 0409-3793-01):  next delivery April.

Product 30 mg/mL; 1mL vial (NDC 0409-3795-01): next delivery February.
 
Product 30 mg/mL; 1 mL Carpuject(NDC 0409-2287-31): next delivery April.
 
Product 60 mg/mL; 2 ml vial (NDC 0409-3796-01):  next delivery January.
 
 
NOTE:  Products  30 mg/mL; 2 mL Carpuject (NDC 0409-2287-61) and 15 mg/mL; 1 mL Carpuject (NDC 0409-2288-31):  suspended production until 2013 due to manufacturing line prioritization.

 

Labetalol Hydrochloride Injection (updated 1/30/2012)

Company/ProductsReasonRelated Information

Bedford Customer Service
1-800-562-4797
Labetalol injection 5 mg/mL,
20 mL vials (NDC 55390-0130-20)
40 mL vials (NDC 55390-0130-40)
 

Manufacturing delays

Bedford has all labetalol presentations on backorder and the company cannot estimate a release date.
 
Akorn Customer Service 1-800-932-5676
Labetalol injection 5 mg/mL
20 mL vials (NDC 17478-0420-20)
40 mL vials (NDC 17478-0420-40)		Increased demandAkorn is releasing product as it becomes available and has increased production to meet current increased demand.
 

Hospira, Inc. Customer Service: 1-877-946-7747
5 mg/mL; 20 mL vial
(0409-2267-20)


5 mg/mL; 40 mL vial
(0409-2267-54)

5 mg/mL; 4 mL syringe
(0409-2339-34)

Higher than anticipated market demand

Product 5 mg/mL; 20 mL vial (NDC 0409-2267-20):  ample levels of inventory to support market demand.

Product 5 mg/mL; 40 mL vial (NDC 0409-2267-54):  ample levels of inventory to support market demand.

Product 5 mg/mL; 4 mL syringe (NDC 0409-2339-34):  next delivery January.


Please check with your wholesaler for all available inventory.


 
Sagent pharmaceuticals, Inc. 866-625-1618
20 mL vials (NDC 25021-0300-20)
40 mL vials (NDC 25021-0300-40)		Increased demand

Sagent has the 20mL and 40mL products available.


 

 

L-cysteine hydrochloride  (10/18/2011)

Company/ProductsReasonRelated Information

American Regent/Luitpold
631-924-4000

50 mg/mL
10 mL vial (NDC 00517-2050-05) 50 mL vial (NDC 00517-2064-25)

Manufacturing delays

American Regent has L-cysteine hydrochloride injection on back order and the company cannot estimate a release date.
Sandoz Customer Service:
1-609-627-8500

50 mg/mL
10 mL vial (NDC 66758-0004-02)
50 mL vial (NDC 66758-0005-02)

Increased demandSandoz has L-cysteine hydrochloride injection 50 mL and 10 mL vials on back order and the company estimates a release date of end of November, 2011.

 

Leucovorin Calcium Lyophilized Powder for Injection (updated 12/16/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797		Manufacturing delaysBedford  has all leucovirin presenations on backorder and the company cannot estimate a release date.
Teva Pharmaceuticals
1-800-545-8800		Manufacturing delaysTeva, in conjunction with the FDA, is initiating a temporary importation of Leucovorin Calcium Folinate Solution for Injection, to the United States market to address the current shortage.
See Dear Healthcare Professional letter (PDF 692KB) for additional information.
APP Pharmaceuticals
1-888-386-1300		Increased demandAPP is currently back-ordered due to increased demand. Intermittent releases expected Q1-2012. (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV).

 

Leuprolide Injection  (updated 7/19/2011)

Company/ProductsReasonRelated Information
Teva
1-800-545-8800

1 mg/0.2 ml (NDC 00703-4014-18)

Manufacturing delaysCurrently on backorder, anticipate release is Q411.
Sandoz
1-609-627-8500

1 mg/0.2 ml (NDC 00185-7400-85)

Increase in demandOn intermittent backorder, anticipate release October 2011.
Caraco
313-871-8400

1 mg/0.2 ml (NDC 41616-0936-40)

Increase in demandOn intermittent backorder.

 

Levaquin Injection  (updated 12/6/2011)

Company/ProductsReasonRelated Information

Janssen Pharmaceuticals, Inc.:
1-800-Janssen (1-800-526-7736)

 

Levaquin Injection

250 mg in 50 mL Dextrose 5%, premix bag (NDC 50458-0167-01)
 

500 mg in 100 mL Dextrose 5%, premix bag (NDC 50458-0168-01)
 

750 mg in 150 mL Dextrose 5%, premix bag (NDC 50458-0166-01)

Manufacturing delaysJanssen Pharmaceuticals, Inc. is experiencing intermittent back orders on all Pre-mixed IV bag presentations of Levaquin due to manufacturing delays and are releasing product as it becomes available.

 

Levofloxacin Injection  (updated 12/12/2011)

Company/ProductsReasonRelated Information
Akorn Pharmaceuticals
1-800-932-5676

25 mg/mL, 20 mL vial (NDC 17478-0107-20)

25 mg/mL, 30 mL vial (NDC 17478-0107-30)

Increased DemandAkorn has levofloxacin 25 mg/mL 20 mL and 30 mL vials on intermittent back order and the company is releasing product as it becomes available.
Sagent pharmaceuticals, Inc.
1-866-625-1618

250 mg_50 mL Premix Bag NDC 25021-132-81

500 mg_100 mL Premix Bag NDC 25021-132-82

750 mg_150 mL Premix Bag NDC 25021-132-83

N/ASagent has all 3 strengths available for contracted customers only.  Additional batches are expected in January.
Sandoz
Customer Service:
1-609-627-8500

250 mg in 50 mL Dextrose 5%, premix bag (NDC 00781-3341-09)

500 mg in 100 mL Dextrose 5%, premix bag (NDC 00781-3342-09)

750 mg in 150 mL Dextrose 5%, premix bag (NDC 00781-3343-09)

Manufacturing delaysSandoz has all levofloxacin presentations on back order and releasing product as it becomes available.

 

Levoleucovorin (Fusilev) 50 mg single use vials (updated 7/7/2011)

Company/ProductsReasonRelated Information
Spectrum Pharmaceuticals
1-877-387-4538 or 1-877-FUSILEV		 Fusilev (levoleucovorin) for Injection 50 mg vials (NDC 68152-101-00) are available from Spectrum Pharmaceuticals in ample quantities. Based upon the current and anticipated inventory, Spectrum Pharmaceuticals is able to meet all present and future demand. Please call the Company directly at 1-877-387-4538 to obtain Fusilev which is now approved for CRC.

Reminder: There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg).

For more information visit: Spectrum Pharmaceuticals disclaimer icon web site. 

 

Lorazepam Injection (updated 1/24/2012)

Company/ProductsReasonRelated Information

West-Ward Pharmaceuticals

Customer Service:
1-800-631-2174
(Formerly a Baxter Product)

 

Ativan (lorazepam) Injection

2 mg/mL, 1 mL vial
(NDC 60977-112-01)

2 mg/mL, 10 mL vial,

(NDC 60977-116-02)

4 mg/mL, 1 mL vial
(NDC 60977-113-01)

4 mg/mL, 10 mL vial,

(NDC 60977-113-02)

 

Lorazepam Injection, USP

2 mg/mL, 1 mL vial
(NDC 10019-102-01)

2 mg/mL, 10 mL vial,

(NDC 10019-102-10)

4 mg/mL, 1 mL vial
(NDC 10019-103-01)

4 mg/mL, 10 mL vial,

(NDC 10019-103-10)

Increase in product demand.

West-Ward is currently experiencing a backorder situation on the Ativan and Lorazepam 2 mg/mL, 1 mL vials and also the Lorazepam 4 mg/mL, 1 mL vial. 

 

All other presentations of Ativan and Lorazepam are available in limited quantities.

 

West-Ward has accelerated production on Ativan and Lorazepam 2 mg/mL, 1 mL vial codes and will have additional lots availability in the November – December 2011 timeframe.

Product will be made available as it is released.

Bedford Laboratories Customer Service:
1-800-562-4797

2 mg/mL, 1 mL vial (NDC 55390-0168-10), 10 mL vial (NDC 55390-0170-10)

Not currrently marketed.Product Discontinued: Bedford currently has all presentations discontinued.

Hospira Inc. Customer Service:
1-877-946-7747

2 mg/mL; 1 mL vial
(NDC 00409-6778-02)


2 mg/mL; 10 mL vial
(NDC 0409-6780-02)


2 mg/mL; 1 mL Carpuject syringe
(NDC 0409-1985-30)


2 mg/mL; 1 mL iSecure syringe
(NDC 0409-1985-05)
 
4 mg/mL; 1 mL vial
(NDC 0409-6779-02)


4 mg/mL; 10 mL vial
(NDC 0409-6781-02)


4 mg/mL; 1 mL
Carpuject syringe (NDC 0409-1539-31)

Manufacturing delay

Product 2 mg/mL; 10 mL vial (NDC 0409-6780-02):  next delivery April 2012.

 

Product 2 mg/mL; 1 mL Carpuject syringe (NDC 0409-1985-30):  next delivery January 2012.

Product 4 mg/mL; 1 mL vial (NDC 0409-6779-02):  next delivery in April 2012.

Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02):  next delivery in April 2012.


Product 2 mg/mL; 1 mL vial (NDC 0409-6778-02):  next delivery in April 2012.

Please note that 4 mg/mL; 1 mL Carpuject syringe (NDC 0409-1539-31) is temporarily unavailable.

 

Please note that 2 mg/mL; 1 mL iSecure prefilled syringe (NDC 0409-1985-05) has been discontinued.


Please check with your wholesaler for available inventory.

Akorn:
847-279-6100		N/A

Akorn has Lorazepam injection 2 mg/mL, 1 mL vials on intermittent back order and are filling direct orders and shipping to wholesalers as product becomes available.

.

 

Magnesium Sulfate Injection (updated 1/25/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

500 mg/mL, 2 mL vial (NDC 63323-0064-02), 500 mg/mL, 10 mL vial (NDC 63323-0064-10), 500 mg/mL, 20 mL vial (NDC 63323-0064-20), 500 mg/mL, 50 mL vial (NDC 63323-0064-50)

APP has magnesium sulfate injection on shortage due to increased demand for the product.APP has all magnesium sulfate 500 mg/mL presentations on intermittent back order and the company is releasing the product as it becomes available.
American Regent/Luitpold
631-924-4000

500 mg/mL, 2 mL vial (NDC 00517-2602-25), 500 mg/mL, 10 mL vial (NDC 00517-2610-25), 500 mg/mL, 50 mL vial (NDC 00517-2650-25)

Manufacturing delaysAmerican Regent has all magnesium sulfate 500 mg/mL presentations on back order and the company cannot estimate a release date.
Hospira, Inc. Customer Service
1-877-946-7747

    

50%; 20 mL vial

(NDC 0409-2168-02)

 

50 %; 10 mL Ansyr syringe

(NDC 0409-1754-10)

 

40 mg/mL-water; 50 mL bag

(NDC 0409-6729-24)

 

40 mg/mL-water; 100 mL bag

(NDC 0409-6729-23)

 

40 mg/mL-water; 500 mL bag

(NDC 0409-6729-03)

 

40 mg/mL-water; 1000 mL bag

(NDC 0409-6729-09)

 

10 mg/mL-dextrose; 100 mL bag

(NDC 0409-6727-23)

 

80 mg/mL-water; 50 mL bag

(NDC 0409-6730-13)

Manufacturing delayProduct 50 %; 20 mL vial (NDC 0409-2168-02):  next delivery March.

Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next delivery March.
 
Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24):  next delivery January.
 
Product 40 mg/mL-water; 100 mL bag (NDC 0409-6729-23):  next delivery January.
 
Product 40 mg/mL-water; 500 mL bag (NDC 0409-6729-03):  next delivery February.
 
Product 40 mg/mL-water; 1000 mL bag (NDC 0409-6729-09):  next delivery February.
 
Product 10 mg/mL-dextrose; 100 mL bag (NDC 0409-6727-23):  next delivery January.
 
Product 80 mg/mL-water; 50 mL bag (NDC 0409-6730-13):  next delivery January.

Please check with your wholesaler for available inventory.

 

 

Mannitol Injection (updated 2/1/2012)

Company/ProductsReasonRelated Information
APP
Customer Service:
1-888-386-1300

250 mg/mL, 50 mL vial, 25 count
(NDC 63323-0024-25)

Increase in product demand.APP has increased production and will have intermittent releases of product.
B. Braun Medical Inc.
Customer Service:
1-800-227-2862

20% Mannitol Injection USP
L5781 500 mL flexible plastic container NDC 0264-7578-10
 
L5782 250 mL flexible plastic container NDC 0264-7578-20

No shortageB. Braun has increased manufacturing forecast due to an increase in demand. B. Braun has inventory of the 500 mL and  250 mL product  available and is scheduled to have additional product available mid February 2012.
Hosprira, Inc.
Customer Service
1-877-946-7747

25%; 50 mL vial
(NDC 0409-4031-01)

20%; 250 mL container
(NDC 0409-7715-02)

20%; 500 mL container
(NDC 0409-7715-03)

Manufacturing delay

Product 25%; 50 mL vial (NDC 0409-4031-01):  next delivery February.

 

Product 20%; 250 mL container (NDC 0409-7715-02):  next delivery 1Q 2012.

 

Product 20%; 500 mL container (NDC 0409-7715-03):  next delivery 1Q 2012.

 

Please check with your wholesaler for all available inventory.

Luitpold Pharmaceuticals, Inc.
Customer Service:
1-800-645-1760

Mannitol Injection
USP 25% 50 mL vial
NDC 0517-4050-25

Increase in product demandMannitol Injection, USP 25%, 50 mL vial on back order and the company estimates a release date of January 2012.

 

Mesna 100 mg/mL Injection  (updated 1/31/2012)

Company/ProductsReasonRelated Information
Sagent Pharmaceticals:
1-866-625-1618

10 mL vials, 1 count (NDC 25021-0201-10)

10 mL vials, 10 count (NDC 25021-0201-11)

Manufacturing delaysThe 10mL 1 count is on backorder and the 10 count product is on allocation.
APP:
1-888-386-1300

10 mL vial, 1 count (NDC 63323-0773-11)

10 mL vial, 10 count (NDC 63323-0773-10)

AvailableAPP has available both 10 mL vials in the 1 count and 10 count.
Bedford:
1-800-562-4797

10 mL vial, 1 count (NDC 55390-0045-01)

Manufacturing delaysBedford has mesna injection on back order and the company cannot estimate a release date.
Teva:
1-800-545-8800

10 mL vial, 10 count (NDC 00703-4805-03)

Manufacturing delaysAnticipating release of product Q212/Q312.
Baxter Customer Service:
1-800-ANA-DRUG
(1-800-262-3784)

10 mL vial, 1 count (NDC 10019-0953-01)

10 mL vial, 10 count (NDC 10019-0953-02)

Mesnex 100 mg/mL Injection,
10 mL vial, 1 count (NDC 00338-1305-01)

10 mL vial, 10 count (NDC 00338-1305-03

Increase in demandSeveral releases planned for November and December.

 

Methotrexate Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information
APP Customer Service

1-888-386-1300

25 mg/mL; 2 mL vial;
With Preservative
(NDC 63323-0123-02)

25 mg/mL; 10 mL vial;
With Preservative
(NDC 63323-0123-10)

Discontinuation of 2ml vials.
 
Increased demand.		Product 25 mg/mL; 2 mL vial (NDC 63323-0123-02) discontinued.
 
Product 25 mg/mL; 10 mL vial (NDC 63323-0123-10) available.
Bedford Customer Service 1-800-562-4797

25 mg/mL; 2 mL vial; Preservative Free
(NDC 55390-0031-10)
25 mg/mL; 4 mL vial; Preservative Free
(NDC 55390-0032-10)
25 mg/mL; 8 mL vial; Preservative Free
(NDC 55390-0033-10)
25 mg/mL; 10 mL vial; Preservative Free
(NDC 55390-0034-10) 

Methotrexate lyophilized powder for injection
1 gram vial; (NDC 55390-0143-01

Bedford Laboratories has multiple products affected by the suspension of manufacturing at Ben Venuedisclaimer icon in mid-November 2011. Availability of all products, including those not manufactured at Ben Venue, is updated as information changes on the Bedford Laboratories websiteBedford has all methotrexate injections on back order and the company cannot estimate a release date. The 10 mL preservative-free vials and 1 gram lyophilized powder for injection are pending release once manufacturing and distribution resumes while the other presentations will not be produced until capacity permits.
Hospira, Inc. Customer Service
1-877-946-7747

25 mg/mL; 2 mL vial
With Preservative
(NDC 61703-350-38)

25 mg/mL; 40 mL vial;
Preservative Free
(NDC 61703-408-41)

Higher than anticipated market demand.

Product 25 mg/mL; 2 mL vial (NDC 61703-350-38):  next delivery April.
 
Product 25 mg/mL; 40 mL vial (NDC 61703-408-41): next delivery March.

Mylan Institutional
1-888-258-4199

25mg/ml; 2ml vial
Preservative Free
(NDC 10139-0062-02)

25 mg/ml; 10ml vial
Preservative Free
(NDC 10139-0062-10)

25 mg/ml; 40ml vial
Preservative Free
(NDC 10139-0062-40)

Significant increase in demand.

Limited quantity of 2ml vials (NDC 10139-0062-02) available for emergency drop ship orders.

40ml vials (NDC 10139-0062-40) expiration of April 2012 and May 2012 are available via drop ship orders.

As additional product becomes available, it will continue to be allocated via drop ship orders.

Sandoz Customer Service:
1-609-627-8500

25mg/ml; 2ml vial
Preservative Free
(NDC 66758-0040-02)

25mg/ml; 10ml vial
Preservative Free
(NDC 66758-0040-08)

25mg/ml; 40ml vial
Preservative Free
(NDC 66758-0041-01)

Manufacturing delays

Sandoz has temporarily discontinued 2ml (NDC 66758-0040-02) and 10ml (NDC 66758-0040-08) vials.

Experiencing a back order on 40ml vials.

 

Methylphenidate HCl (updated 1/12/2012)

Company/ProductsReasonRelated Information
Sandoz Customer Service:
1-609-627-8500

5 mg (100s - NDC 00781-8840-01 & 00781-5748-01; 1000s - NDC 00781-8840-10), 10 mg (100s - NDC 00781-5749-01 & 00781-8841-01; 1000s - NDC 00781-1749-10), 20 mg (100s - NDC 00781-8842-01 & 00781-5753-01; 1000s - NDC 00781-1753-10)

20 mg (100s - NDC 00781-8843-01 & 00781-5754-01)

Capacity constraints and receiving API orders.Expect sporadic backorders for the next couple of months.
Mallinckrodt Customer Service:
(800) 325-8888

5 mg (100s - NDC 00406-1121-01; 1000s - NDC 00406-1121-10), 10 mg (100s - NDC 00406-1122-01; 1000s - NDC 00406-1122-10), 20 mg (100s - NDC 00406-1124-01; 1000s - NDC 00406-1124-10) Methylin ER, 10 mg (100s - NDC 00406-1423-01) and 20 mg (100s - NDC 00406-1451-01)

Continued recovery as a result of previously unavailable raw material

All strengths of methylphenidate IR and ER tablets will be increasingly available as supply recovery continues, with most contracted orders being met.

UCB Customer Service:
1-800-477-7877

5 mg (100s - NDC 53014-0531-07), 10 mg (100s - NDC 53014-0530-07), and 20 mg (100s - NDC 53014-0532-07)

Metadate ER Tablets, 20 mg (100s - NDC 53014-0594-07)

Metadate CD, 10 mg (100s - NDC 53014-0579-07), 20 mg (100s - NDC 53014-0580-07), 30 mg (100s - NDC 53014-0581-07), 40 mg (100s - NDC 53014-0582-07), 50 mg (100s - NDC 53014-0583-07), and 60 mg (100s - NDC 53014-0584-07)

Increased demand

UCB is currently out of stock of our 5 mg IR, 10 mg IR and 20 mg IR and our 20 mg ER products.  UCB expects resupply by February.

Watson Customer Service:
(973) 355-8300

5 mg (100s - NDC 00591-5882-01), 10 mg (100s - NDC 00591-5883-01), and 20 mg (100s - NDC 00591-5884-01)

n/aWatson has all 3 strengths available for contracted customers only.

Noven Customer Service:
866.663.2539 

Daytrana (Methylphenidate Transdermal System)


10 mg (30s - NDC 68968-5552-3) 

15 mg (30s - NDC 68968-5553-3) 

20 mg (30s - NDC 68968-5554-3) 

30 mg (30s - NDC 68968-5555-3)

Not applicable

Currently all product is available

 

Metoclopramide injection (updated 1/27/2012)

Company/ProductsReasonRelated Information

West-Ward Pharmaceuticals Customer Service:
(1-888-229-0001)

(Formerly a Baxter Product)

5 mg/mL, 2 mL vial, 25 count (NDC 10019-0450-02)

Increased DemandWest-Ward is currently experiencing an increase in demand for metoclopramide injection 5 mg/mL, 2 mL vials (NDC 10019-0450-02). Lots are currently being manufactured and will be release for distribution as product becomes available.
Hospira Inc. Customer Service:
1-877-946-7747

5 mg/mL 2 mL vials (NDC 00409-3414-01)

Manufacturing delay.

Product 5 mg/mL; 2 mL vial (NDC 0409-3414-01):  next delivery March.
Hospira discontinued Metoclopramide Carpuject syringes in May, 2009 and ampules in February, 2010.

Please check with your wholesaler for available inventory.

Teva Pharmaceuticals
1-800-545-8800

5 mg/mL, 2 mL vial, 25 count (NDC 00703-4502-04)

 Teva has made a business decision to discontinue this product. See the Dear Valued Customer Letter (PDF - 32KB)

 

Mexiletine Capsules (150mg, 200mg, and 250mg) (9/24/2010)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800		Manufacturing DelaysTeva has mexiletine 150 mg capsules (NDC 00093-8793-01) and 250 mg capsules (NDC 00093-8741-01). There is not yet an availability date for the 200 mg capsules.

 

Midazolam Injection (updated 1/27/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

1 mg/mL, 2 mL vial, 25 count (NDC 63323-0411-12)

1 mg/mL, 5 mL vial, 25 count (NDC 63323-0411-25)

1 mg/mL, 10 mL vial, 10 count (NDC 63323-0411-10)

5 mg/mL, 5 mL vial, 10 count (NDC 63323-0412-05)

5 mg/mL, 10 mL vial, 10 count (NDC 63323-0412-10)

5 mg/mL, 2 mL vial, 25 count (NDC 63323-0412-02)

5 mg/mL, 1 mL fill in 2 mL vial, 25 count (NDC 63323-0412-25)

Increased demandAPP has midazolam injection on intermittent back order and the company is releasing product on a regular basis. Check with wholesalers for inventory.
Bedford
Customer Service:
1-800-562-4797

1 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0137-02)

1 mg/mL, 5 mL preservative-free vial, 10 count (NDC 55390-0137-05)

1 mg/mL, 10 mL vial, 10 count (NDC 55390-0125-10)

5 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0138-02)

5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01)

5 mg/mL, 5 mL vial, 10 count (NDC 55390-0126-05)

5 mg/mL, 10 mL vial, 10 count (NDC 55390-0126-10)

Temporary suspension of manufacturing.

Bedford has all midazolam presentations on back order and the company cannot estimate a release date.

 

The 1 mg/mL 2 mL and 10 mL vials and the 5 mg/mL 2 mL (1 mL fill), 5 mL and 10 mL vials vials are pending release while the other presentations will not be manufactured until capacity permits.

 

Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories manufactured products.  Availability of products is updated on the Bedford Laboratories website

Hospira, Inc.
Customer Service:
1-877-946-7747

1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 0409-2306-62)

1 mg/mL, 2 mL preservative-free vial (NDC 0409-2305-17)

1 mg/mL, 5 mL preservative-free vial (NDC 0409-2305-05)

1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 0409-2306-12)

1 mg/mL, 10 mL vial (NDC 0409-2587-05)

5 mg/mL, 1 mL preservative-free vial (NDC 0409-2308-01)

5 mg/mL, 5 mL vial (NDC 0409-2596-03)

5 mg/mL, 10 mL vial (NDC 0409-2596-05)

5 mg/mL, 1 mL preservative-free Luer-Lock syringe (NDC 0409-2307-60)

5 mg/mL, 2 mL preservative-free vial (NDC 0409-2308-02)

Other manufacturer shortage/withdrawal; Manufacturing delay; Quality improvement activities.

Product 1 mg/mL, 2 mL preservative-free Luer-lock syringe (NDC 0409-2306-62):  next delivery April.

 

Product 1 mg/mL, 2 mL preservative-free vial (NDC 0409-2305-17):  next delivery January.

 

Product 1 mg/mL, 5 mL preservative-free vial (NDC 0409-2305-05):  next delivery January.

 

Product 1 mg/mL, 2 mL preservative-free iSecure syringe (NDC 0409-2306-12):  next delivery April.

 

Product 1 mg/mL, 10 mL vial (NDC 0409-2587-05):  next delivery January.

 

Product 5 mg/mL, 1 mL preservative-free vial (NDC 0409-2308-01):  next delivery January.

 

Product 5 mg/mL, 5 mL vial(NDC 0409-2596-03):  next delivery February.

 

Product 5 mg/mL, 10 mL vial (NDC 0409-2596-05):  next delivery January.

 

Product 5 mg/mL, 1 mL preservative-free Luer-Lock syringe (NDC 0409-2307-60):  next delivery 2013.

 

Product 5 mg/mL, 2 mL preservative-free vial (NDC 0409-2308-02):  next delivery January.

 

Hospira discontinued the following products:
1 mg/mL, 2 mL iSecure syringe (NDC 0409-2306-22)
5 mg/mL, 1 mL preservative-free iSecure syringe (NDC 0409-2307-21)

West-Ward (formerly Baxter products)
Customer Service:
(1-888-229-0001)

1 mg/mL, 2 mL vial, 10 count (NDC 10019-0028-02)

1 mg/mL, 2 mL dosette vial (NDC 10019-0028-03)

1 mg/mL, 5 mL vial, 10 count (NDC 10019-0028-05)

1 mg/mL, 10 mL vial, 10 count (NDC 10019-0028-10)

1 mg/mL, 2 mL vial, 25 count (NDC 10019-0028-04)

1 mg/mL, 2 mL latex free vial, 10 count (NDC 10019-0028-01)

5 mg/mL, 1 mL vial, 10 count (NDC 10019-0027-06)

5 mg/mL, 1 mL vial, 25 count (NDC 10019-0027-09)

5 mg/mL, 2 mL vial, 25 count (NDC 10019-0027-08)

5 mg/mL, 2 mL vial, 10 count (NDC 10019-0027-07)

5 mg/mL 10 mL vial, 10 count (NDC 10019-0027-10)

Increase in product demand

West-Ward is currently experiencing a backorder situation on all 1 mg/mL and 5 mg/mL vials.


West-Ward has accelerated production on all codes and will have the following products available.


Lots of the1 mg/mL, 2 mL vials will be released and available at the end of January 2012.


Additional lots of the other codes are scheduled to be manufactured and estimated availability in the February - March 2012 timeframe.
Product will be made available as it is released.

 

Mitomycin Powder for Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
Accord Customer Service:
919-941-7879

5 mg (NDC 16729-0115-05)
20 mg (NDC 16729-0108-11)
40 mg (NDC 16729-0116-38)

Increase in demandAccord is releasing products as they become available.
Bedford Laboratories:
1-800-562-4797

5 mg (NDC 55390-0251-01), 20 mg (NDC 55390-0252-01), 40 mg (NDC 55390-0253-01)

Manufacturing delaysBedford has all mitomycin presentations on backorder and the company cannot estimate a release date.

 

Morphine Sulfate Injection  (updated 1/25/2012)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service:
1-877-946-7747

25 mg/mL; 10 mL vial

(NDC 0409-1135-02)

4 mg/mL; 1 mL Carpuject

(NDC 0409-1258-30)

2 mg/mL; 1 mL Carpuject

(NDC 0409-1762-30)

0.5 mg/mL; 10 mL vial

(NDC 0409-3814-12)

 

1 mg/mL; 10 mL vial

Manufacturing delayProduct 25 mg/mL; 10 mL vial (NDC 0409-1135-02):  next delivery April.
 
Product 4 mg/mL; 1 mL Carpuject (NDC 0409-1258-30):  next delivery January.
 
Product 2 mg/mL; 1 mL Carpuject (NDC 0409-1762-30):  next delivery January.
 
Product 0.5 mg/mL; 10 mL vial (NDC 0409-3814-12):  next delivery February.
 
Product 1 mg/mL; 10 mL vial (NDC 0409-3815-12):  next delivery April.
 
Product 25 mg/mL; 4 mL Add-vantage vial (NDC 0409-6177-14):  next delivery March.
 
Product 10 mg/mL; 2 mL Carpuject (NDC 0409-1261-30):  next delivery March.
 
Product 8 mg/mL; 2 mL Carpuject (NDC 0409-1260-69):  next delivery April.
 
Please check with your wholesaler for available inventory.

 

Multi-Vitamin Infusion (Adult and pediatric) (updated 12/30/2011)

Company/ProductsReasonRelated Information
Hospira , Inc.
Customer Service
1-877-946-7747

MVI-12 Adult; 10 mL vial (NDC 61703-423-81)
MVI-12 Adult; 2x50 mL PBP(NDC 61703-423-83)
MVI Adult; 10 mL vial (NDC 61703-422-81) MVI Adult; 2x5 mL (NDC 61703-422-82) MVI Adult 2x50 mL PBP (NDC 61703-422-83)
MVI Pediatric; 5 mL vial (NDC 61703-421-53)

Manufacturing delays

MVI Pediatric 5 mL vial (NDC 61703-421-53):  ample levels of inventory to support market demand. 

 

All Adult formulations:  Hospira is working to restore adequate supply.  The following products are targeted for market return in 2012:

-MVI-12 Adult; 2x50 mL PBP (NDC 61703-423-83)

 

-MVI Adult; 2x5 mL (NDC 61703-422-82)

 

-MVI Adult 2x50 mL PBP (NDC 61703-422-83)

Baxter (Infuvite adult and pediatric IV solution)
Customer Service:
1-888-229-0001		Manufacturing delaysInfuvite is now available for Baxter.

 

Mustargen (mechlorethamine HCl) injection (updated 1/6/2012)

Company/ProductsReasonRelated Information
Lundbeck Inc.
Customer service number:
1-888-514-5204		See Related Information

Lundbeck has transferred production of Mustargen to a new manufacturing site and is in the process of securing supplies to reintroduce the product

 

Lundbeck expects Mustargen to be available again during second quarter 2012. Updates will be provided as they become available.


Please see the Dear Healthcare Professional Letter (PDF - 24KB) from Lundbeck for additional information.

 

Nalbuphine Injection (updated 1/13/2012)

Company/ProductsReasonRelated Information
Hospira
1-877-946-7747

NDC and Product Description:
10 mg/mL; 1 mL amp NDC 0409-1463-01

10 mg/mL; 10 mL vial NDC 0409-1464-01

20 mg/mL; 1 mL amp NDC 0409-1465-01

10 mg/mL; 10 mL vial NDC 0409-1467-01

Other manufacturer shortages/market withdrawal.

Product 20 mg/mL; 1 mL amp (NDC 0409-1465-01): next delivery in April.


Hospira has all other presentations available with ample levels of inventory to support market demand.


Please check with your wholesaler for available inventory.

 

 

 

 

NeoProfen (ibuprofen lysine) Injection (updated 12/15/2011)

Company/ProductsReasonRelated Information
Lundbeck Inc.
Customer service number:
1-888-514-5204		Failure to meet a visible particulate quality specification.Lundbeck voluntarily recalled NeoProfen as a safety precaution. As NeoProfen stock is being replenished by the manufacturer, supply is anticipated to be available in second quarter 2012.

 

Neostigmine methylsulfate injection (updated 11/15/2011)

Company/ProductsReasonRelated Information

West-Ward Pharmaceuticals Customer Service:
(1-888-229-0001)

(Formerly a Baxter Product)

0.5 mg/mL vials (NDC 10019-0271-10), West-Ward 1 mg/mL, 10 mL vial (NDC 10019-0270-10)

Increased demandWest-Ward has available neostigmine 1 mg/mL, 10 mL vials (NDC 10019-0270-10). The 0.5 mg/mL 10 mL vials are on back order and there is not yet a reported release date.
American Regent/Luitpold
631-924-4000

0.5 mg/mL 10 mL vials (NDC 00517-0034-25) and 1 mg/mL 10 mL vials (NDC 00517-0033-25)

Increased demandAdditional information regarding supplies of 0.5 mg/mL 10 mL vials (NDC 00517-0034-25), 1 mg/mL 10 mL vials (NDC 00517-0033-25) will be posted as soon as it's available.
APP
1-888-386-1300

0.5 mg/mL, 10 mL vial (NDC 63323-0382-10), 1 mg/mL 10 mL vials (NDC 63323-0383-10)

Increased demandAPP has all Neostigmine Injection 0.5 mg/mL & 1 mg/mL presentations available.

 

Neupro (rotigotine transdermal system) (5/5/2010)

Company/ProductsReasonRelated Information
UCB, Inc
800-477-7877		UCB has recalled all domestic lotsFDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation.

If you have additional questions about the status of Neupro, or about UCB’s Patient Access program for Neupro, please contact UCB Medical Information at 1-866-822-0068 (option 9).

 

Norepinephrine Bitartrate Injection (updated 12/2/2011)

Company/ProductsReasonRelated Information
Bedford Customer Service:
1-800-562-4797

(Bedford 4 mL vial, package of 10 (NDC 55390-0002-10))

Manufacturing delays

Bedford has norepinephrine on back order and the company cannot estimate a release date.

Hospira Inc.
1-877-946-7747

1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04)

Available

Levophed (Norepinephrine Bitartrate Injection)

 

Products 1 mg/mL; 4 mL ampule (NDC 0409-1443-04) and 1 mg/mL; 4 mL vial (NDC 0409-3375-04):  ample levels of inventory to support market demand.


Please check with your wholesaler for available inventory. 

Teva Pharmaceuticals
1-800-545-8800

(Teva 4 mL vial, package of 10 (NDC 00703-1153-03))

Teva temporarily discontinued norepinephrine in June 2010.Teva anticipates having product available again 4th quarter 2011.
Sandoz Inc. Sandoz, in conjunction with the FDA, is initiating a temporary importation of Norepinephrine Injection, to the United States market.

Please see the Dear Healthcare Professional Letter (PDF - 296KB) for information about emergency supplies that are now available to help address the shortage.

 

Ondansetron Injection 2 mg/mL (updated 1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

2 mL vials, package of 25 (NDC 63323-0373-02)

Increased demandAPP has Ondansetron 2 mg/mL 2 mL vials on back order with an estimated release date of late March 2012.

 

Limited quantities of the 20 mL multiple dose vials (NDC 63323-0374-20) are available.

Bedford
Customer Service:
1-800-562-4797

1 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0137-02)

1 mg/mL, 5 mL preservative-free vial, 10 count (NDC 55390-0137-05)

1 mg/mL, 10 mL vial, 10 count (NDC 55390-0125-10)

5 mg/mL, 2 mL preservative-free vial, 10 count (NDC 55390-0138-02)

5 mg/mL, 1 mL preservative-free, in 2 mL vial, 10 count (NDC 55390-0138-01)

5 mg/mL, 5 mL vial, 10 count (NDC 55390-0126-05)

5 mg/mL, 10 mL vial, 10 count (NDC 55390-0126-10)

20 mL vial (NDC 55390-0121-01)

2 mL vials, packages of 10 (NDC 55390-0121-10) - discontinued
2 mL Novaplus vials, packages of 10 (NDC 55390-0307-10) - discontinued 20 mL Novaplus vials, packages of 1 (NDC 55390-0307-01) - discontinued

Temporary suspension of manufacturing.

Bedford has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate a release date. Bedford Laboratories has multiple products affected by this temporary suspension of manufacturing. Bedford will have the affected, as well as the available products, listed on their website and are updating this information as it changes. The company voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis for maintenance and requalification of equipment. Product will become available in stages as production resumes.

Bedford discontinued the following products:
2 mL vials, packages of 10 (NDC 55390-0121-10)
2 mL Novaplus vials, packages of 10 (NDC 55390-0307-10)
20 mL Novaplus vials, packages of 1 (NDC 55390-0307-01)

Apotex

2 mL vials, package of 5 (NDC 60505-0744-01)

20 mL multiple dose vial (NDC 60505-0744-06)

Pending informationPending information
Caraco
313-871-8400

2 mL ampules (NDC 62756-0181-01)

20 mL vials (NDC 62756-0182-01)

 Caraco temporarily discontinued ondansetron injection
Cura

2 mL vials, packages of 5 (NDC 46860-0087-06)

Pending informationPending information
Hospira, Inc.
Customer Service:
1-877-946-7747

2 mg/mL; 2 mL vials (NDC 0409-4755-03)

2 mg/mL; 20 mL vials (NDC 0409-4759-01)

0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24

Other manufacturer shortage/withdrawal; Quality improvement activities.Product 2 mg/mL; 2 mL vial (NDC 0409-4755-03): next delivery January.
 
Product 2 mg/mL; 20 mL vial (NDC 0409-4759-01):  next delivery January.

Product 0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24):  next delivery 2012.

Product 2 mg/mL; 2 mL iSecure syringe (NDC 0409-1120-12):  next delivery March.

Please check with your wholesaler for available inventory.

West-Ward (formerly Baxter products)

Customer Service:
1-800-631-2174
(Formerly a Baxter Product)

2 mg/mL, 2 mL vial (NDC 0641-6078-25)

 

2 mg/mL, 20 mL

Vial (0641-6079-01)

Increase in product demand.

West-Ward is currently experiencing a backorder situation on both the 2 mL and 20 mL vials.

 

West-Ward has accelerated production and is projecting to have additional lots available in the January - February 2012 timeframe.

 

Product will be made available as it is released.

Teva
1-800-545-8800

20 mL vials (NDC 00703-7226-01)

2 mL vials, packages of 5 (NDC 00703-7221-02) - discontinued

 

Teva discontinued ondansetron 2 mL vials in 5 count packages.

Teva has the following available:
2 mL vials, package of 25 (NDC 00703-7221-04)
20 mL vials, package of 10 (NDC 00703-7226-03)
Teva has ondansetron 20 mL vials on allocation.

GlaxoSmithKline
Customer Service:
1-888-825-5249

Zofran injection, 2 mg/mL,
2 mL vials, packages of 5
(NDC 00173-00442-02)

20 mL vial
(NDC 00173-0442-00)

 GlaxoSmithKline has the following available:

20 mL vial (NDC 00173-0442-00)

GlaxoSmithKline has discontinued Zofran 2 mL vials

Wockhardt

2 mL vials, package of 5 (NDC 64679-0726-01)

20 mL vials, package of 1 (NDC 64679-0727-01))

Increased demandWockhardt has all presentations of Ondansetron 2 mg/mL on back order with an estimated release date of February 2012.

Pfizer
1-800-533-4535

 

Ondansetron
4 mg/2mL x 25 count
(preservative fee, latex free) NDC 0069-1340-16

40mg/20mL x 1 MDV NDC 0069-1340-02

 Pfizer has the following presentations of ondansetron 2 mg/mL available:

2 mL vials, package of 25 (NDC 0069-1340-16)
20 mL vials, package of 1 (NDC 0069-1340-02)

 

Ondansetron Injection 32 mg/50 mL premixed bags (updated 1/6/2012)

Company/ProductsReasonRelated Information
Claris

32 mg/50 mL (NDC 36000-0014-06)

Pending informationPending information
Sagent Pharmaceuticals
1-866-625-1618

32 mg/50 mL (NDC 25021-0776-50) - discontinued

DiscontinuedSagent has discontinued their ondansetron premixed bags.
Teva Pharmaceuticals
1-800-545-8800

32 mg/50 mL (NDC 00703-7239-39)

Manufacturing delayTeva has ondansetron 32 mg/50 mL premixed bags on back order and the company cannot estimate a release date.
Hospira, Inc.
Customer Service:
1-877-946-7747

0.64 mg/mL; 50 mL bag
(32 mg/50 mL)
(NDC 0409-4760-24)

Other manufacturer shortage/withdrawal; Quality improvement activities.Product 0.64 mg/mL; 50 mL bag (32 mg/50 mL) (NDC 0409-4760-24):  next delivery 2012.
West-Ward Pharmaceuticals
Customer Service:
(1-888-229-0001)

32 mg/50 mL
(NDC 00143-9771-06)

Pending informationPending information
Baxter
Customer Service:
1-888-229-0001

32 mg/50 mL (NDC 00338-1762-41)

No shortageBaxter has the 32 mg/50 mL premixed bags available.

 

Ontak injection (9/22/2011)

Company/ProductsReasonRelated Information
Eisai
1-888-422-4743

150 mcg/mL, Eisai
2 mL vial (NDC 62856-0603-01)

Manufacturing issueEisai is working to have product available again. For information on Patient Access Program, please visit: http://www.ontak.com/disclaimer icon

 

Orphenadrine Citrate Injection (updated 1/30/2012)

Company/ProductsReasonRelated Information
Akorn:
847-279-6100

30 mg/mL, 2 mL vial, 10 count (NDC 17478-0538-02)

Increased demandAkorn has all presentations of orphenadrine citrate injection on back order and with an estimated a release date of mid-February, 2012.
Bedford:
Orphenadrine citrate injection
30 mg/mL

Bedford
2 mL vial, 10 count (NDC 55390-0059-10)

Bedford currently not producing. 

Sagent:
1-866-625-1618
 

30 mg/mL, 2 mL vial, 10 count (NDC 25021-0651-02)

Manufacturing delays

Sagent has all presentations of orphenadrine citrate injection on allocation and additional shipments are expected in February.

Watson:
Orphenadrine citrate injection

30 mg/mL, 2 mL vial, 10 count (NDC 00591-3222-47)

Information pendingInformation pending

 

Oxsoralen (methoxsalen) 1% topical lotion (7/6/2010)

Company/ProductsReasonRelated Information
Valeant Pharmaceuticals International
1-866-819-9007		Manufacturing delaysThere is not yet an estimated release date.

 

Oxytocin Injection, USP (synthetic) (12/22/2011)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

10 mL MDV (10 USP units/mL)
(NDC 63323-012-10)

1 mL SDV (Plastic Vial) (10 USP units/mL)
(NDC 63323-012-01)

30 mL MDV (10 USP units/mL)
(NDC 63323-012-30)

Increase in demand

10 mL vial on back-order with an estimated release date of early to mid-February 2012.

 

1 mL vial available with an estimated release date of mid-January 2012

 

30 mL vial available. Estimated release date TBD.

JHP Pharma
1-877-547-4547

1 mL vial (10 USP units/mL)
(NDC 42023-116-25)

10 mL vial (10 USP units/mL)
(NDC 42023-116-01)

10 mL vial (10 USP units/mL)
(NDC 42023-116-02)

Increase in demand

1 mL SDV is currently on short-term back-order. Company has increased production with an estimated release date of early February 2012.

 

10 mL vial in 1 and 25s: Available in adequate stock.

 

Please see product status memo: Short Term Backorder Status Letter (PDF - 95KB)

West-Ward Pharmaceuticals
Customer Service:
1-888-229-0001

1mL vial (10 USP units/mL) (NDC10019-291-02)

10 mL vial (10 USP units/mL)
(NDC 10019-291-04

Information pendingInformation pending

 

Paclitaxel Injection  (updated 1/30/2012)

Company/ProductsReasonRelated Information
Sandoz:
1-800-525-8747
6 mg/mL injection

30 mg/5 mL vial (NDC 66578-0043-01) 100 mg/16.7 mL vial (NDC 66578-0043-02) 300 mg/50 mL vial (NDC 66578-0043-03)

Manufacturing delaysSandoz is currently on backorder.
APP
1-888-386-1300
6 mg/mL injection

30 mg/5 mL vial (NDC 63323-0763-05)
100 mg/16.7 mL vial (NDC 63323-0763-16)
300 mg/50 mL vial (NDC 63323-0763-50)

 

Increase in demandAPP is on intermittent back order and is releasing product as it becomes available.

Hospira Inc. Customer Service:
1-877-946-7747

300 mg/50 mL vial (NDC 0409-0342-50)

30 mg/5 mL vial (NDC 0409-0342-09)

100 mg/16.7 mL vial (NDC 0409-0342-22)

Higher than anticipated market demand.Product 30 mg/5 mL vial (NDC 0409-0342-09): ample levels of inventory to support market demand.
 
Product 300 mg/50 mL vial (NDC 0409-0342-50):  next delivery February.
 
Product 100 mg/16.7 mL vial (NDC 0409-0342-22): next delivery March.

Please check with your wholesaler for available inventory.

 

Bedford Laboratories
1-800-562-4797
6 mg/mL injection

30 mg/5 mL vial (NDC 55390-0114-05)
100 mg/16.7 mL vial (NDC 55390-0114-20)
300 mg/50 mL vial (NDC 55390-0114-50)

Manufacturing delaysBedford has all paclitaxel presentations  on backorder and the company cannot estimate a release date.
Teva
1-800-545-8800
6 mg/mL injection

30 mg/5 mL vial (NDC 00703-4764-01)
100 mg/16.7 mL vial (NDC 00703-4766-01)
150 mg/25 mL vial (NDC 00703-4767-01)
300 mg/50 mL vial (NDC 00703-4768-01)

Manufacturing delaysTeva expecting releases of 16.7 mL, 25 mL, and 50 mL
Sagent Pharmaceticals
1-866-625-1618

30mg/5mL
NDC 25021-213-05

100mg/16.7mL
NDC 25021-213-17

300mg/50mL
NDC 25021-213-50

 Sagent has the 5mL and 16.7mL on allocation and the 50mL product is available.

 

Pancuronium Bromide Injection (updated 11/23/2011)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

1 mg/mL; 10 mL vial
(NDC 0409-4646-01)

Manufacturing delayProducts 1 mg/mL; 10 mL vial (NDC 0409-4646-01): next delivery April 2012.

 

Phentolamine Mesylate for Injection (updated 12/2/2011)

Company/ProductsReasonRelated Information
Bedford Customer Service:
1-800-562-4797

Phentolamine mesylate for injection, 5 mg lyophilized vial (NDC 55390-0113-01)

Manufacturing delayBedford has phentolamine on backorder and the company cannot estimate a release date.

 

Phenylephrine HCl Injection (updated 7/19/2011)

Company/ProductsReasonRelated Information
West-Ward Pharmaceuticals Customer Service:
1-888-229-0001 (Formerly a Baxter Product)

10 mg/mL, 1 mL (25s - NDC 10019-163-12)

Increase in product demand

West-Ward currently has available inventory.  West-Ward has accelerated production and will have additional lots available for release in July and August.

.
Sandoz Customer Service:
1-609-627-8500

10 mg/mL, 5 mL (25s - NDC 66758-0016-04); 10 mg/mL, 10 mL (1 - NDC 66758-0017-01)

Sandoz is currently on backorder as the current market requirements are more than current inventory due to the shortage in the market.Sandoz anticipates increased product availability by the end of July.
American Regent Customer Service:
1-800-645-1706

10 mg/mL, 1 mL (25s - NDC 00517-0299-25) and 10 mg/mL, 5 mL (25s - NDC 00517-0405-25)

Manufacturing delaysAmerican Regent has available phenylephrine 10 mg/mL 1 mL (NDC 00517-0299-25) and 5 mL (NDC 00517-0405-25) vials.

 

Phytonadione Injectable Emulsion (Vitamin K) (updated 1/4/2012)

Company/ProductsReasonRelated Information
Hospira, Inc.
Customer Service:
1-877-946-7747

1 mg/0.5 mL; 0.5 mL amp
(NDC 0409-9157-01)

10 mg/mL; 1 mL amp
(NDC 0409-9158-01)

Manufacturing delay

Product 1 mg/0.5 mL; 0.5 mL amp (NDC 0409-9157-01): next delivery February. 

 

Product 10 mg/mL; 1 mL amp (NDC 0409-9158-01):  next delivery February.

 

Please check with your wholesaler for available inventory.

Amphastar Pharmaceuticals, Inc./IMS
1-800-423-4136

Vitamin K injection, contains polysorbate 80 and propylene glycol

1 mg/0.5 mL, SAF-T-JET prefilled syringe (NDC 00548-1240-00)

1 mg/0.5 mL, MINIJET prefilled syringe (NDC 00548-1140-00)

Amphastar is not experiencing a shortage. This shortage is due to increased demand and Amphastar has increased production to meet demand.Amphastar reports availability. Please note that Vitamin K injection, contains polysorbate 80 and propylene glycol.

 

Potassium Phosphate (updated 1/13/2012)

Company/ProductsReasonRelated Information

Hospira Inc.
(1-877-946-7747)

 

3 mMol/mL; 15 mL vial

(NDC 0409-7295-01)

Return to market upon FDA request.

Product 3 mMol/mL; 15 mL vial (NDC 0409-7295-01):  next delivery June.

American Regent American Regent anticipates releasing 3 mMol/mL, 50 mL vial (NDC 00517-2350-25) vials mid-July.

 

Primaquine Phosphate Tablets  (updated 12/6/2011)

Company/ProductsReasonRelated Information
Sanofi-aventis U.S. LLC
1-800-633-1610

26.3 mg, 100 count (NDC 0024-1596-01)

Manufacturing issuesSanofi-aventis U.S. is working to restore supply as soon as possible.


Expect product availability in January 2012.

 

Procainamide HCL Injection (updated 11/23/2011)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

100 mg/mL; 10 mL vial

(NDC 0409-1902-01)

500 mg/mL; 2 mL vial

(NDC 0409-1903-01)

Manufacturing delays

Product 500 mg/mL; 2 mL vial (NDC 0409-1903-01):  next delivery in April 2012.

Product 100 mg/mL; 10 mL vial (NDC 0409-1902-01):  ample levels of inventory to support market demand.

Please check with your wholesaler for available inventory.

 

Prochlorperazine InjectionNew! (1/30/2012)

Company/ProductsReasonRelated Information
Bedford Customer Service
1-800-562-4797

5 mg/mL

2 mL vial, 10 count (NDC 55390-0077-10)

10 mL vial (NDC 55390-0077-01)

Manufacturing delaysBedford has both prochlorperazine 5 mg/mL injection presentations on back order and the company cannot estimate a release date. The 2 mL vials are pending release while the 10 mL vials will not be manufactured until capacity permits.

 

 

Selenium injection (10/28/2011)

Company/ProductsReasonRelated Information
American Regent/Luitpold:
631-924-4000

40 mcg/mL, 10 mL vial (NDC 00517-6610-25)

Manufacturing delaysAmerican Regent has selenium injection on back order and the company cannot estimate a release date.

 

Sodium Acetate InjectionNew! (1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

2 mEq/mL, 100 mL vial (NDC 63323-0032-61)

Increased in demandAPP has sodium acetate on back order and estimates a release date in mid-March.

 

Sodium Chloride 23.4% (updated 1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

30 mL vials (NDC 63323-0087-30)
100 mL vials (NDC 63323-0088-61)
200 mL vials (NDC 63323-0088-63)

Increased demandAPP has sodium chloride 23.4% solution for injection on intermittent back order and the company is releasing product as it becomes available.
American Regent, Inc.
1-800-645-1706

30 mL vials (NDC 00517-2930-25), 100 mL vials (NDC 00517-2900-25)

Increased demandAmerican Regent has sodium chloride 23.4% solution 30 mL vials and 100 mL vials are on back order and cannot estimate a release date.
Hospira Inc. Customer Service:
1-877-946-7747

4 mEq/mL; 250 mL bottle (NDC 0409-1130-02)
4 mEq/mL; 100 mL bottle (NDC 0409-1141-02)

Manufacturing delay

Product 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02):  expected availability is TBD.

Product 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02):  expected availability is TBD.

 

 

Sodium Chloride 14.6% Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information
Hospira Inc. Customer Service:
1-877-946-7747

2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73)
2.5 mEq/mL; 40 mL vial (NDC 0409-6660-75)

Available

Products 2.5 mEq/mL; 40 mL vial (NDC 0409-6660-75) and 2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73):  ample levels of inventory to support market demand.

APP
1-888-386-1300

20 mL vials (NDC 63323-0139-20)
40 mL vials (NDC 63323-0139-40)

Increased demandAPP has sodium chloride 14.6% solution for injection 40 mL vials are available. The 20 mL vials are on long-term back order with no estimated release date.

 

Sodium Phosphate Injection (updated 1/25/2012)

Company/ProductsReasonRelated Information
Hospira, Inc. Customer Service:
1-877-946-7747

3 mmol/mL, 15 mL vial (NDC 00409-7391-72)

Other manufacturer shortage/market withdrawal and Manufacturing delay.

Product 3 mmol/mL; 15 mL vial (NDC 0409-7391-72):  next delivery in February.

American Regent/Luitpold
631-924-4000

5 mmol/mL, 5 mL vial (NDC 00517-3405-25), 5 mmol/mL, 15 mL vial (NDC 00517-3415-25), 5 mmol/mL, 50 mL vial (NDC 00517-3450-25)

Manufacturing delaysAmerican Regent expects mid August release for  sodium phosphate 5 mmol/mL 5 mL (NDC 00517-3405-25), 15 mL (NDC 00517-3415-25), and 50 mL (NDC 00517-3450-25) vials.

 

Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP) (8/5/2010)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800		Teva recalled Lot #31308526B/Exp. Date 9/2012 of SMX/TMP Injection 10 ml vials to the retail level because some vials may have defective crimps.Teva manufactures 5 ml vials (NDC 00703-9503-03), 10 ml vials (NDC 00703-9514-03) and 30 ml vials (NDC 00703-9526-01). Limited emergency supplies are available from Teva.

 

Telavancin (Vibativ) Injection (updated 1/6/2012)

Company/ProductsReasonRelated Information
Astellas Pharma US, Inc.
1-800-727-7003

NDC 00469-3575-50
PDS 750 mg

NDC 00469-3525-30
PDS 250 mg

Manufacturing delays

Astellas has no estimated date of availability.

 

See the Dear Health Care Provider Letter (PDF - 142KB)

 

Tetracycline Capsules  (11/8/2011)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800

250 mg, 100 count (NDC 00172-2416-60)

250 mg, 100 count unit dose (NDC 00172-2416-10)

250 mg, 1000 count (NDC 00172-2416-80)

500 mg, 100 count (NDC 00172-2407-60)

500 mg, 100 count unit dose (00172-2407-10)

500 mg, 1000 count (NDC 00172-2407-80)

Manufacturing delaysTeva has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date.
Watson
Customer Service:
(973) 355-8300

250 mg, 100 count (NDC 00591-2234-01)

250 mg, 1000 count (NDC 00591-2234-10)

500 mg, 100 count (NDC 00591-2235-01)

500 mg, 1000 count (NDC 00591-2235-10)

Manufacturing delaysWatson has all tetracycline capsules temporarily unavailable and the company cannot estimate a release date.

 

Thiotepa for Injection (updated 12/2/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797

15 mg/mL vial (NDC 55390-0030-10)

Manufacturing delaysBedford has thiotepa on backorder and the company cannot estimate a release date.
Adienne Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 1MB) for information about emergency supplies that are now available to help address the shortage.

 

Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated 11/22/2011)

Company/ProductsReasonRelated Information
Genzyme Corporation
1-800-745-4447		Temporary DelaysIntermittent shipments of the product have resumed globally.  Genzyme continues to expect that Thyrogen supply constraints will occur through 2012.

 

Thyrolar Tablets (12/31/2009)

Company/ProductsReasonRelated Information
Forest PharmaceuticalsManufacturing delaysForest has not yet reported when Thyrolar will be available.

 

Ticlopidine Tablets  (11/23/2011)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800

250 mg, 100 count (NDC 00093-0154-01)

Manufacturing delaysTeva has ticlopidine tablets on back order and the company estimates a release date in first quarter, 2012.
Apotex Corporation Customer Service:
1-(877)-4-Apotex

250 mg, 30 count (NDC 60505-0027-02)

250 mg, 60 count (NDC 60505-0027-04)

250 mg, 500 count (NDC 60505-0027-07)

Manufacturing delaysApotex has ticlopidine tablets on back order and the company estimate a release date of February, 2012.

 

Tobramycin Solution for Injection (updated 1/31/2012)

Company/ProductsReasonRelated Information

Teva Pharmaceuticals
1-800-545-8800

40 mg/mL, 2 mL vial (NDC 00703-9402-04)

 

40 mg/mL, 30 mL vial (NDC 00703-9416-01)

Manufacturing delaysTeva has all tobramycin 40 mg/mL solution for injection on long term back order and the company cannot estimate a release date.

Pfizer Injectables
1-800-533-4535

40 mg/mL, 2 mL vial (NDC 00069-0088-02)

 

40 mg/mL, 30 mL vial (NDC 00069-0091-03)

Manufacturing delaysPfizer tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company estimates a release date of mid-December 2011.

APP
1-888-386-1300

10 mg/ml; 2ml vial (NDC 63323-0305-02)
40 mg/mL, 2 mL vial (NDC 63323-0306-02)
40 mg/mL, 30 mL vial (NDC 63323-0306-30)
 
40 mg/mL, 50 mL vial (NDC 63323-0307-51)

40 mg/mL, 2 mL  Novaplus vial (NDC 63323-0306-55)
 
40 mg/mL, 30 mL Novaplus vial (NDC 63323-0306-56)

Tobramycin Lyophilized Powder for Injection
1.2 gram 50 mL vial, preservative-free, 6 count (NDC 63323-0303-51)
 1.2 gram 50 mL Novaplus vial, preservative-free, 6 count (NDC 63323-0303-55)

Increase in demand/manufacturing delaysThe 40 mg/mL 2 mL vials are on back order with an estimated release date of mid-February, 2012.
 
APP has tobramycin solution for injection 40 mg/mL 2 mL vials on intermittent back order. Product may be available at wholesalers.

The 40 mg/mL 50 mL vials are on back order with an estimated release date of  mid-February, 2012.  The NovaPlus vials are available.  Please check wholesaler inventory for both.
 
APP has available tobramycin 1.2 gram lyophilized powder for injection presentations. Please check wholesaler inventory.

Hospira, Inc.
Customer Service
1-877-946-7747

10 mg/mL; 2 mL vial
(NDC 0409-3577-01)

40 mg/mL; 2 mL vial
(NDC 0409-3578-01)

40 mg/mL; 50 mL vial
(NDC 0409-3590-02)

Other manufacturer shortage/market withdrawal.

Product 10 mg/mL; 2 mL vial (NDC 0409-3577-01): next delivery June.

 

Product 40 mg/mL; 2 mL vial (NDC 0409-3578-01): next delivery March.

 

Product 40 mg/mL; 50 mL vial (NDC 0409-3590-02): next delivery March.

 

Please check with your wholesaler for available inventory.

 

Vecuronium Injection (updated 12/30/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797		Increase in demandBedford has all vecurionium presentations on backorder and the company cannot estimate a release date.
Sun Pharmaceutical Industries, Inc.
1-800-818-4555		Increase in demandSun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available.

Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44

Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44

Teva Pharmaceuticals
1-800-545-8800		On manufacturing holdTeva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder.
Hospira, Inc. Customer Service:
1-877-946-7747

10 mg vial (NDC 0409-1632-01)

 

20 mg vial (NDC 0409-1634-01)

Manufacturing delay

Product 20 mg vial (NDC 0409-1634-01):  next delivery March 2012.

 

Product 10 mg vial (NDC 0409-1632-01):  temporarily suspended

 

Sagent Pharmaceticals
1-866-625-1618

10mg/vial
NDC 25021-657-10

 

20mg/vial
NDC 25021-658-20

 Sagent has both the 10mg and 20mg product available.

 

Vinblastine Sulfate InjectionNew! (1/31/2012)

Company/ProductsReasonRelated Information
APP
1-888-386-1300

1 mg/mL; 10 mL vial (NDC 63323-0278-10)

Increased demandAPP has vinblastine sulfate injection on back order with an estimated release date of mid-February, 2012.

 

Vincristine Sulfate Injection (updated 1/13/2012)

Company/ProductsReasonRelated Information
Hospira Inc.
Customer Service: 1-877-946-7747

1 mg/mL; 1 mL vial
(NDC 61703-309-06)

 

1 mg/mL; 2 mL vial
(NDC 61703-309-16)

Available

Product 1 mg/mL; 1 mL vial (NDC 61703-309-06): ample levels of inventory to support market demand.
 

Product 1 mg/mL; 2 mL vial (NDC 61703-309-16):  ample levels of inventory to support market demand.

 

Please check with your wholesaler for available inventory.  

Teva Pharmaceuticals
1-800-545-8800		 Teva has 1 mg/mL 1 mL vial (NDC 00703-4402-11) and 2 mL vial (NDC 00703-4412-11) now available and is shipping to wholesalers.

 

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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#cocaine

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