Current Drug Shortages: Cyanocobalamin injection

 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 6/3/2011)

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

100 mg/mL; 30 mL vial

(NDC 04098-3307-03)

200 mg/mL; 30 mL vial

(NDC 0409-3308-03)

Higher than anticipated market demand.

Products 100 mg/mL; 30 mL vial (NDC 0409-3307-03) and 200 mg/mL; 30 mL vial (NDC 0409-3308-03):  May delivery received; next release in July.

 

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)

Increase in demandRoxane Labs anticipates releases in late May 2011 for acetylcysteine inhalation solution 100 mg/mL 10 mL (NDC 00054-3027-02) and 30 mL (NDC 00054-3025-02) vials and 200 mg/mL 10 mL and 30 mL vials.
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 has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date.

 

Amikacin Injection (updated 6/20/2011)

CompanyReasonRelated Information

Teva Pharmaceuticals
1-800-545-8800

Manufacturing delaysTeva has amikacin 250 mg/mL 2 mL (NDC 00703-9032-03) and 4 mL (NDC 00703-9040-03) vials on allocation. If a pharmacy cannot obtain product from their wholesaler, please have the wholesaler contact Teva directly to place an emergency order.
Bedford Customer Service
1-800-562-4797
Manufacturing delays250 mg/mL, 2 mL vials, package of 10 (NDC 55390-0226-02) – Available in 10 pack presentation
250 mg/mL, 4 mL vials, package of 10 (NDC 55390-0226-04) – Available in 10 pack presentation

 

Amino Acid Injection (updated 6/8/2011)

Company/ProductsReasonRelated Information

Hospira Customer Service
1-877-946-7747

Aminosyn II 10%; 1000 mL

NDC 0409-4164-05

Commodity shortage
 
The next release of this product is expected in July which will achieve target inventory levels to support demand.  Potential short term alternative is NDC 0409-4164-03 (Aminosyn II 10% 500mL) which has inventory available.

 
All other Aminosyn products are available with ample levels of inventory to support recent demand.

Baxter Customer Service:
1-888-229-0001

Adequate supply is now available.

Baxter has the following bulk pharmacy Amino Acid Injections available through normal distribution. 

Clinisol, Baxter
Clinisol 15%, 500 mL (NDC 00338-0502-03)
Clinisol 15%, 2000 mL (NDC 00338-0502-06)

Prosol, Baxter Prosol 20%, 2000 mL (NDC 00338-0499-06)

Travasol, Baxter
Travasol 10%, 500 mL (NDC 00338-0644-03)
Travasol 10%, 1000 mL (NDC 00338-0644-04) Travasol 10%, 2000 mL (NDC 00338-0644-06)

B Braun Customer Service
1-800-227-2862
Increase in demand

All FreAmine 10% (S9010-SS & S9011-SS), TrophAmine 10% (S9341-SS) , and TrophAmine 6%( S9361-SS) products are off allocation and currently available to all customers via direct or indirect distribution, as inventory is very healthy to support new customers.

Feel free to contact your local B. Braun sales representative or place orders via Customer Service at 800-227-2862.

 

Ammonium Chloride Injection (updated 6/3/2011)

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:  company estimates a release date of 3rd quarter, 2011.

 

Please check with your wholesaler for available inventory.

 

Ammonium molybdate injection New! (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 6/10/2011)

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.Expect increased product availability in May 2011. Shire Customer Service Number: 1-800-828-2088 Shire Pharmacy Locator Number: 1-800-828-2088 select “Option 5” for assistance in locating a pharmacy in your area with product availability.
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.

 

Aquasol A, 50,000 units/mL, 2 mL ampule (NDC 61703-418-07) (12/7/2010)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Change in manufacturing sites.Hospira anticipates releasing product sometime in 2011.

 

Arginine 10% injection (R-Gene 10) (11/30/2010)

 

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 6/20/2011)

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.   The 15 unit is estimated to release mid-July and 30 unit is estimated to release early-August.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing dela

Teva has bleomycin 15 unit and 30 unit vials on back order and anticipates release by end of August 2011.

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)

Higher than anticipated market demand.

 Product 15 unit vial (NDC 61703-332-18):  releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct.  Next delivery expected in August.

Product 30 unit vial (NDC 61703-323-22):  releases received weeks of June 6 and June 13, however, supply is tight and being managed through allocation from Hospira direct.  Next delivery expected in July.

 

Calcitriol 1 mcg/mL Injection  (updated 6/20/2011)

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 mL ampule, 50 count (NDC 63323-0731-01

Increase in demandAPP has calcitriol injection on intermittent back order with multiple releases estimated by Late-May.
Abbott Laboratories
1-800-255-5162

1 mL ampule, 100 count (NDC 00074-8110-31)

Manufacturing delaysAbbott has Calcijex 1 mcg/mL injection on back order with an estimated release date of early August 2011.
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.

 

Calcium Chloride Injection (updated 5/18/2011)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
 Hospira has product available.
American Regent, Inc.
1-800-645-1706
 American Regent, Inc. is not currently releasing Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial. Information on releases will be posted once available.
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 (4/1/2011)

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 all calcium gluconate products on intermittent back-order, due to increased demand, and the company has regular releases and distributes inventory directly to the wholesale channel.

Please check with your wholesaler for all available inventory. APP has the 10mL vials (63323-311-10) and 100mL vials (63323-311-61) on back-order with estimated releases mid-March, 2011. APP has the 50mL vials (63323-311-50) also on backorder with estimated release early-April, 2011. The 200mL vials have been discontinued.

Luitpold
631-924-4000

50 mL (NDC 0051703950-25), and 100 ml NDC (00517-3900-25) vials

Increase in demandAmerican Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order. The 10 mL vials have been discontinued.

 

Cisplatin injection 1 mg/mL solution (updated 5/10/2011)

Company/ProductsReasonRelated Information
APP
1-888-386-1300
Increased DemandAPP is continuing to allocate as releases occur: 50 mL vial (NDC 63323-0103-51), 100 mL vial (NDC 63323-0103-65) and 200 mL vial (NDC 63323-0103-64).
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.

 

Cleviprex 0.5 mg/mL 50 mL vial (NDC 65293-0002-50) 100 mL vial (NDC 65293-0002-00)(updated 6/14/2011)

Company/ProductsReasonRelated Information
The Medicines CompanySee Related Information SectionThe Medicines Company has Cleviprex 0.5mg/ml 50 ml vials (NDC 65293-0002-50) available by drop shipment through wholesalers.  The 100ml vials do not yet have an availbillity date.

 

Cyanocobalamin injection New! (6/21/2011)

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

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

Increase in demandAPP has cyanocobalamin injection on intermittent back order and the company is releasing product as it becomes 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 cyanocobalamin injection 1 mL and 10 mL vial sizes available. The 30 mL vial size is on backorder.

 

Cytarabine Injection (updated 6/16/2011)

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

100 mg vial (NDC 55390-0131-10)
500 mg vial (NDC 55390-0132-10)
1 gram vial (NDC 55390-0133-01)
2 gram vial (NDC 55390-0134-01)

Manufacturing delaysBedford has cytarabine 1 gram vials on intermittent back order and the company is releasing product as it becomes available. All other cytarabine presentations are on back order and the company cannot estimate a release date.
APP
1-888-386-1300

100 mg/mL, 20 mL vial (NDC 63323-0120-20)

Manufacturing delaysLimited supplies available - please see attached Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage and estimates additional supplies to be released by end of April.
Hospira Inc.
1-877-946-7747

20 mg/mL; 50 mL PBP (NDC 61703-303-46), 20 mg/mL; 25 mL (NDC 61703-304-36), 20 mg/mL; 5 mL (NDC 61703-305-38), 100 mg/mL 20 mL (NDC 61703-319-22)

Higher than anticipated market demand.

Products 20mg/ml; 50 mL PBP (NDC 61703-303-46): next release in June.

Product 20 mg/mL; 5 mL (NDC 61703-305-38) and 20 mg/mL; 25mL (NDC 61703-304-36): next release in July.

Product 100 mg/mL; 20 mL (NDC 61703-319-22): available now with next release in June.

Please check with your wholesaler for available inventory.

Dear Healthcare Professional Letter (PDF - 75KB)

 

Daunorubicin hydrochloride solution for injection  (updated 5/10/2011)

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 will release 20 mg lyophilized powder for injection in early May. Bedford will release daunorubicin solution for injection, 20 mg and 50 mg, in the next 3-months.

 

Desmopressin Injection (updated 6/3/2011)

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)

n/aFerring is continuing to release product as soon as it becomes available.
Hospira Inc. Customer Service:
1-877-946-7747

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

 

Product 4 mcg/mL; 1 mL amp (NDC 0409-2265-01):  ample levels of inventory to support market demand.

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 demandSanofi is continuing to release product as soon as it becomes available.
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 6/10/2011)

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 all dexamethasone 4mg/mL and 10mg/mL presentations on intermittent back order and the company is releasing the product as it becomes available.  APP will have releases throughout June, July, and August to respond to the increased demand..

 

Digoxin Injection (updated 5/5/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service:
1-888-229-0001

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

Increase in product demand.Baxter is currently experiencing a back order situation on the 2 mL ampuls (NDC 0641-1410-35). Baxter has accelerated production and will have product available by the end of April.
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 6/16/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service
1-888-229-0001

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

25 mL vial (NDC 10019-510-04)

Baxter has accelerated production due to an increase in product demand.Baxter 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.

 

Products 5 mg/mL; 5 mL (NDC 0409-1171-01) and 5 mg/mL; 10 mL vial (NDC 0409-1171-02) and 100 mg/mL; ADD-Vantage vial (NDC 0409-4350-03): continuous deliveries with product currently available.

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 anticipates release of all presentations in the next 3 months.

 

Doxorubicin (adriamycin) lyophilized powder (updated 5/10/2011)

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 anticipates release of all presentations in the next 6-months.

 

Doxorubicin Solution for Injection (updated 5/10/2011)

Company/ProductsReasonRelated Information
APP
1-888-386-1300
APP Product Availability Informationdisclaimer icon
Increased demandAPP is releasing the 2mg/ml 100 ml vials (NDC 63323-0101-61), the 2mg/ml 25 ml vials (NDC 63323-0883-30), and the 2mg/ml 5 ml vials (NDC 63323-0883-05) as it becomes available.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva is releasing all strengths on allocation: 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).
Bedford
1-800-562-4797
Manufacturing delaysBedford anticipates release of the 50mg presentation in the next 3months and release of the 10 mg, 25 mg, and 100 mg solutions in the next 6-months.

 

Erythromycin lactobionate injection (6/16/2011)

Company/ProductsReasonRelated Information

Hospira Inc.
1-877-946-7747

500 mg vial
(NDC 0409-6482-01)
500 mg Add-Vantage vial
(NDC 0409-6476-44)

 

Both presentations: ample levels of inventory to support market demand.

 

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 6/16/2011)

Company/ProductsReasonRelated Information
Bedford
1-800-562-4797
Increased demandBedford estimates releasing the 5ml vials (NDC 55390-0291-01) at the end of June and the 25ml vials (NDC 55390-0292-01) mid-June, 2011. 
No estimated date of availability for the 50ml vials (NDC 55390-0293-01).
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
Manufacturing delaysAPP is releasing all etoposide solution for injection 20 mg/mL presentations as they become available.
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

20mg/5mL, 100mg vial (NDC#16729-114-31)

N/AAccord healthcare has product available.

 

Fabrazyme (agalsidase beta) (3/25/2011)

 

Foscarnet Sodium Injection (updated 6/3/2011)

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 letter for information about availability from Clinigen in the UK (PDF - 1.8MB)

 

Fosphenytoin Sodium Injection (updated 6/3/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
1-800-562-4797
Not currently marketedBedford will be off the market for an undefined period of time.
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 delayHospira is working to restore adequate supply, however, no timing is available.
Akorn Pharmaceuticals
1-800-932-5676
Not currently marketedAkorn will be off the market for an undefined period of time.
APP
1-888-386-1300
Increase in demandAPP continues to release product as it becomes 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 has available fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25).

 

Furosemide Injection (updated 6/16/2011)

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 delayProducts 10 mg/mL; 4 mL Ansyr syringe (NDC 0409-9631-04) , 10 mg/mL; 10 mL Ansyr Syringe (NDC 0409-1639-10):  next release in 3rd Quarter 2011.

All other presentations:  ample levels of inventory to support market demand.

Please check with your wholesaler for available inventory.

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
Increase in demandAPP has available furosemide 10 mg/mL injection 2 mL (NDC 63323-0280-02) and 4 mL (NDC 63323-0280-04) vials.

 

Haloperidol Decanoate Injection (updated 5/10/2011)

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 haloperidol decanoate available in 50 mg/mL 5 mL vials (NDC 63323-0469-05). 100 mg/mL 5 mL vials (NDC 63323-0471-05) and 100 mg/mL 1mL vials (NDC 63323-0471-01) and 50 mg/mL 1 mL vials (NDC 63323-0469-01) are being released as they become available.
Bedford Laboratories
Customer Service
1-800-562-4797
Product discontinuedBedford has all presentations of the Haloperidol Decanoate discontinued.

 

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)

 

Leucovorin Calcium Lyophilized Powder for Injection (updated 6/20/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797
Manufacturing delaysBedford anticipates releasing the 50mg lyophilized product ((NDC 55390-0051-10)  at the end of July and the 100mg lyophilized product (NDC 55390-0052-10) ) mid-June, 2011.  The 200mg (NDC 55390-0053-01) and 350mg lyophilized product (NDC 55390-0054-10)  will be released mid June, 2011.  The 500mg solution (NDC 55390-0009-01) will be released at the end of July, 2011.
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
APP has recently launched their leucovorin injection in response to the ongoing shortage.APP is currently back-ordered. Initial supplies are limited, however APP is continuing to produce and release leucovorin calcium lyophilized powder for injection (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV).

 

Levoleucovorin (Fusilev) 50 mg single use vials (updated 5/24/2011)

Company/ProductsReasonRelated Information
Spectrum Pharmaceuticals
1-877-387-4538 or 1-877-FUSILEV
 Spectrum Pharmaceuticals has increased production of Fusilev 50 mg vials (NDC 68152-101-00) and is continuing to release supplies as they become available.

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 Pharmaceuticalsdisclaimer icon web site.

 

Levorphanol 2mg Tablets (6/21/2011)

Company/ProductsReasonRelated Information
Roxane Laboratories
1-614-276-4000
Indefinitely DiscontinuedProduct currently unavailable

 

Lorazepam Injection(updated 6/3/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service:
1-888-229-0001

2 mg/mL, 1 mL vial (NDC 10019-0102-01), 1 mL Novaplus vial (NDC 10019-0105-01), 10 mL vial (NDC 10019-0102-10)

Baxter has accelerated production due to an increase in product demand.Baxter has lorazepam 2 mg/mL, 10 mL vials (NDC 10019-0102-10) currently available for distribution.

The 2 mg/mL, 1 mL vial presentation (NDC 10019-0102-01) will be on back order until the end of April.

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.Bedford has all lorazepam injection presentations on long-term back order and the company cannot estimate a release date.

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)  

Higher than anticipated market demand.
Products 2 mg/mL; 1 mL vial (NDC 0409-6778-02), 2 mg/mL; 10 mL vial (NDC 0409-6780-02) and 2 mg/mL; 1 mL Carpuject syringe (NDC 0409-1985-30): ample levels of inventory to support market demand.

Product 4 mg/mL; 1 mL vial (NDC 0409-6779-02):  next release in June.

Product 4 mg/mL; 10 mL vial (NDC 0409-6781-02):  next release in July.

Please note that 2 mg/mL; 1 mL iSecure prefilled syringe (NDC 0409-1985-05) and 4 mg/mL; 1 mL Carpuject syringes (NDC 0409-1539-31) are temporarily unavailable.

Please check with your wholesaler for available inventory.

Akorn:
847-279-6100
N/AAkorn has Lorazepam injection available.

 

Magnesium Sulfate Injection (updated 6/16/2011)

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

550%; 20 mL vial (NDC 0409-2168-02) 40 mg/mL; 50 mL bag (NDC 0409-6729-24), 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10)

Higher than anticipated market demand.Product 50%; 20 mL vial (NDC 0409-2168-02): May delivery received; next release in June. Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): next release in June. Product 50 %; 10 mL Ansyr syringe (NDC 0409-1754-10): next release in August.

Please check with your wholesaler for available inventory.

 

Methylphenidate HCl (updated 6/7/2011)

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)

This shortage is due to Active Pharmaceutical Ingredient (API) constraints.Mallinckrodt expects to have continued gradual improvement over the next two months, with full recovery by July 2011.
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 demandUCB is currently in stock in all strengths of our methylphenidate products (IR, ER, and CD) and presentations.
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/aContinues to have product available.

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 6/3/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service:
(1-888-229-0001)

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

Increased DemandBaxter 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)

 Product 5 mg/mL; 2 mL vial (NDC 0409-3414-01):  ample levels of inventory to support market demand.

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.

 

Mustargen (mechlorethamine HCl) injection (9/30/2010)

Company/ProductsReasonRelated Information
Lundbeck Inc.
Customer service number:
1-888-514-5204
See Related InformationLundbeck is currently working closely with FDA to gain approval of the transfer of production of Mustargen to a new manufacturing site after the company’s previous contractor discontinued commercial manufacturing of the product.

Lundbeck expects Mustargen to be available again during 2011. Updates will be provided as they become available.

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

 

Multi-Vitamin Infusion (Adult and pediatric) (updated 6/3/2011)

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 delaysMVI 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, however, no timing is available.

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

 

Nalbuphine Injection (6/16/2011)

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; 1 mL Novaplus amp NDC 0409-1463-49

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

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

20 mg/mL; 1 mL Novaplus amp NDC 0409-1465-49

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 release in July.

Product 20 mg/mL; 1 mL Novaplus amp (NDC 0409-1465-49): available with limited supply.

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 (9/8/2010)

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 mid-2011.

 

Neostigmine methylsulfate injection (6/10/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service:
(1-888-229-0001)

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

Increased demandBoth strengths are on backorder with anticipation to have additional supply available in the March-April timeframe.
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 0.5mg/mL and 1mg/mL presentations on allocation due to increased demand.

 

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 6/1/2011)

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

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

Manufacturing delays

Bedford anticipates release in the next 3-months.

Hospira Inc.
1-877-946-7747

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

Higher than anticipated market demand.Levophed (Norepinephrine Bitartrate Injection) 1 mg/mL; 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) are currently available with continuous deliveries going forward; ample levels of inventory to support market demand are expected by the end of third quarter.

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.

 

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.

 

Oxsoralen-Ultra (methoxsalen) 10 mg capsules (6/17/2010)

Company/ProductsReasonRelated Information
Valeant Pharmaceuticals International
Customer Service
1-800-556-1937
Manufacturing delaysValeant has released limited quantity of Oxsoralen-Ultra 10mg capsules to the market and is committed to ensuring the product is allocated properly to patients in need. Please see the Dear Healthcare Professional Letter (PDF - 49KB) for additional information.

You may also contact Valeant by e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it for additional information.

 

Pentosan Polysulfate sodium 100mg capsulesNew! (5/19/2011)

Company/ProductsReasonRelated Information
Ortho Woman’s Health & Urology

ELMIRON (Pentosan Polysulfate sodium) 100mg capsules
NDC 50458-098-01

Manufacturing delaysOrtho Women’s Health is in backorder for ELMIRON (Pentosan Polysulfate sodium) 100mg capsules. Current estimate on resupply is 2 to 3 months.

Any questions from consumers and/or Health Care Providers should be directed to the Customer Call Center 1-800-526-7736.

 

Phenylephrine HCl Injection (4/25/2011)

Company/ProductsReasonRelated Information
Baxter Customer Service:
1-888-229-0001

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

Increase in product demandBaxter is currently experiencing a back order situation on the 1 mL vial (NDC 10019-163-12) Baxter has accelerated production and will have product available in mid May. Additional lots are scheduled for manufacturing and will be available for distribution in the June – July timeframe.
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 May.
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 cannot estimate a release date at this time.

 

Potassium Phosphate (updated 6/22/2011)

Company/ProductsReasonRelated Information
Hospira Inc.
(1-877-946-7747)
 Hospira, in agreement with FDA, will return to manufacturing Potassium Phosphate Injection to address the critical shortage so that patient needs continue to be met. Hospira understands the critical necessity of this molecule to the healthcare community and is quickly assessing manufacturing re-start timing and anticipated market recovery dates. At this time an ETA is unavailable.
American Regent American Regent anticipates releasing 3 mMol/mL, 50 mL vial (NDC 00517-2350-25) vials mid-July.

 

Procainamide HCL Injection (updated 6/3/2011)

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):  ample levels of inventory to support market demand.

 

Product 100 mg/mL; 10 mL vial (NDC 0409-1902-01):  next release June.

 

Please check with your wholesaler for available inventory.

 

Propofol Injection (updated 6/3/2011)

Company/ProductsReasonRelated Information
Teva Pharmaceuticals
1-800-545-8800
Teva Pharmaceuticals has discontinued their propofol injection.Questions and Answers on the Propofol Shortage
Hospira Inc. 

Customer Service
1-877-946-7747


10 mg/mL; 20 mL (0409-4699-30)
10 mg/mL; 50 mL (0409-4699-33)
10 mg/mL; 100 mL (0409-4699-24)

Higher than anticipated market demand.

Products 10 mg/mL; 20 mL (0409-4699-30), 10 mg/mL; 50 mL (0409-4699-33) and 10 mg/mL; 100 mL (0409-4699-24):  frequent releases.

Please check with your wholesaler for available inventory.

APP
1--888-386-1300
APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section APP has available ALL generic Propofol 1% sizes (20mL, 50mL and 100mL) and generic Novaplus propofol (20 mL, 50mL and 100 mL) vials available through wholesalers and distributors.  Effective May 19, 2011 orders should be placed directly with wholesalers and distribution centers.  See  http://www.apppharma.com/our-products/product-updates.html disclaimer icon for more information.

APP Diprivan (20mL, 50mL and 100mL) and Novaplus Diprivan (20mL, 50mL, and 100 mL) vials are on intermittent back order and the company is releasing product weekly.  These presentations can be ordered direct through APP, or wholesalers can place drop ship orders on the customer's behalf directly with APP.

 

Sodium Chloride 23.4% (updated 6/10/2011)

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 30 mL and 100 mL vials on allocation. The 200 mL vials are on back order and the company estimates a release date of early-April, 2011.
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

Products 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02) and 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02):  expected to be available in late 2011.

 

Sodium Chloride 14.6% Injection (updated 6/16/2011)

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)

Higher than anticipated market demand.
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 with next release in June.
APP
1-888-386-1300

14.6%, 20 mL vials (NDC 63323-0139-20), 40 mL vials (NDC 63323-0139-40)

Increased demandAPP does not yet have a release date.

 

Sodium Phosphate Injection (updated 6/3/2011)

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

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

Manufacturing delayProduct 3 mmol/mL; 15 mL vial (NDC 0409-7391-72): company estimates next release in 3rd Quarter 2011.
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 has sodium phosphate injections on back order and the company cannot estimate a release date.

 

Succinylcholine injection (5/27/2011)

Company/ProductsReasonRelated Information
Sandoz
1-800-525-8747
Increased demandSandoz reports weekly releases are occurring for Anectine 20 mg/mL 10 mL vials (NDC 00781-3009-95)

Hospira
1-877-946-7747

All presentations.

 

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

  

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.

 

Tamiflu for Oral Suspension 12mg/ml 25 ml (NDC 00004-0810-95) (1/19/2011)

Company/ProductsReasonRelated Information
Genentech:
Product support and fulfillment:
1-800-551-2231
For medical information:
1-800-821-8590
Increased demandGenentech has Tamiflu for Oral Suspension on backorder, however supplies remain in distribution at wholesalers and pharmacies. Tamiflu 75mg, 45 mg and 30 mg capsules remain available. For those patients who have difficulty swallowing capsules, the contents can be mixed into sweetened liquids, such as chocolate syrup, as directed by a healthcare professional.

If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available.

Please refer to the Tamiflu package insert for information regarding compounding an oral suspension from Tamiflu 75mg capsules or see the following link for healthcare professionals: Tamifludisclaimer icon

  

Thiotepa for Injection (updated 6/21/2011)

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

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

Manufacturing delaysBedford anticipates release within the next three months.
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.

 

Thyroid (desiccated) tablets (2/12/2011)

Company/ProductsReasonRelated Information
Forest RLCForest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market.FDA approved levothyroxine products continue to be available from multiple manufacturers.

 

Thyrolar Tablets (12/31/2009)

Company/ProductsReasonRelated Information
Forest PharmaceuticalsManufacturing delaysForest has not yet reported when Thyrolar will be available.

 

Tromethamine (updated 6/3/2011)

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

500 mL (NDC 0409-1593-04)

 Product 500 mL (NDC 0409-1593-04):  ample levels of inventory to support market demand.

 

Vasopressin InjectionNew! (6/2/2011)

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

20 units/mL Injection, 0.5 mL multi-dose vial, 25 count (NDC 00517-0510-25), 1 mL multi-dose vial, 25 count (NDC 00517-1020-25), 10 mL multi-dose vial, 25 count (NDC 00517-0410-10)

N/AAmerican Regent has all strengths of vasopressin 20 units/mL injection 1 mL multi-dose vials (NDC 00517-1020-25), 10 mL multi-dose vials (NDC 00517-0410-10), 0.5 mL multi-dose vials available for ordering.
JHP

Pitressin 20 units/mL Injection, 1 mL single-dose vial, 25 count (NDC 42023-0117-25)

N/AJHP has Pitressin on allocation.
APP
1-888-386-1300

20 units/mL Injection, 1 mL single-dose vial, 25 count (NDC 63323-0302-01)

Manufacturing delaysAPP has vasopressin 20 units/mL injection on back order and the company estimates an August release date.

 

Vecuronium Injection (updated 6/3/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797
Increase in demandBedford anticipates release of the 10mg product in early May and the 20mg product in the next 3-months.
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)

Manufacturing delay

.

Hospira will be off-market for an undefined period.

 

Vincristine Sulfate Injection (updated 6/16/2011)

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)


 
Higher than anticipated market demand.

 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):  product available; next release in August.

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.

 

Xeloda 500 Tablets (3/25/2011)

Company/ProductsReasonRelated Information
Genentech
1-800-GENENTECH
Recall of 13 manufacturing lots of the customary 120 count bottles currently approved for use in the US. Genentech is working closely with FDA to ensure that US supply of Xeloda 500mg tablets remains unchanged.Please see the Dear Healthcare Professional Letter (PDF - 95KB).

 

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Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#cyanocobalamin

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