Current Drug Shortages: Buprenorphine injection

Thursday, 21 July 2011 11:42

 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 6/30/2011)

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): Next release in August.

 

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.

 

Alcohol Dehydrated (Ethanol > 98%)New! (7/20/2011)

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 delaysAmerican Regent anticipates releases of the 1 mL and 5mL ampoules at the end of July and August.

 

Amikacin Injection (updated 7/21/2011)

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 amikacin 250 mg/mL 2 mL on intermittent backorder with product available as it is released. The 4 mL presentation does not have estimated estimate release timing.

 

Amino Acid Injection (updated 7/14/2011)

Company/ProductsReasonRelated Information

Hospira Customer Service
1-877-946-7747

All Aminosyn presentations


 		All 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 7/12/2011)

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 has improved for all dosage strengths. 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 7/14/2011)

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):  July delivery received; next release September.
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 August.


Buprenorphine injection  New! (7/21/2011)

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

 

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 (updated 6/24/2011)

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 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.
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 (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 7/21/2011)

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 delaysAPP has 2 gram vials available on allocation. Please see attached Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage.
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) available now with next release in mid August.

 

Product 20 mg/mL; 5 mL (NDC 61703-305-38) and 20 mg/mL; 25mL (NDC 61703-304-36) available now with next release in mid August.

 

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

 

Please check with your wholesaler for available inventory.

Dear Healthcare Professional Letter (PDF - 75KB)

 

Daunorubicin hydrochloride solution for injection  (updated 7/21/2011)

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 Laboratories has limited emergency quantities of 5mg/ml solution. Cerubidine lyophilized powder for injection 20 mg is on backorder and there is not an estimate release date.

 

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 7/14/2011)

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..
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.

 

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 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 Liposomal (Doxil) InjectionNew! (7/18/2011)

Company/ProductsReasonRelated Information
Janssen Products, LP (formerly Centocor Ortho Biotech Products, L.P.)-1-800-526-7736 (1-800-JANSSEN)

2 mg/mL, 10 mL (NDC 17314-9600-01); 25 ml (NDC 17314-9600-02)

Manufacturing delaysEstimated Availability 3rd Quarter, 2011.

 

Doxorubicin Solution for Injection (updated 6/29/2011)

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.
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 7/21/2011)

Company/ProductsReasonRelated Information
Bedford
1-800-562-4797		Increased demandBedford Laboratories has all presentations on back order. The company estimates a release date by end of July for the 5 mL vials and there is not yet an estimated release date for the other presentations.
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 7/21/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
1-800-562-4797		Not currently marketedBedford does not have any reported date of availability.
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 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 reports availability of fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25).

 

Furosemide Injection (updated 7/7/2011)

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 delayProduct 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 7/21/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797		Manufacturing delaysBedford Laboratories has limited emergency quantities of 200mg lyophilized product (NDC 55390-0053-01). Late July is the anticipated release for the 50mg lyophilized product (NDC 55390-0051-10), 100mg lyophilized product (NDC 55390-0052-10) 350mg lyophilized product (NDC 55390-0054-10) and 500mg solution (NDC 55390-0009-01).
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).

 

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.

 

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. 

 

Levorphanol 2mg Tablets (6/21/2011)

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

 

Lorazepam Injection (updated 7/19/2011)

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 available lorazepam 2 mg/mL 1 mL (NDC 10019-0102-01) and 10 mL (NDC 10019-0102-10) vials, 2 mg/mL 1 mL (NDC 10019-0105-01) and 10 mL (NDC 10019-0105-02) Novaplus vials, 4 mg/mL 10 mL (NDC 10019-0103-10) vials, and 4 mg/mL 1 mL (NDC 10019-0106-01) and 10 mL (NDC 10019-0106-02) Novaplus vials. The 4 mg/mL 1 mL vial is on back order with no estimated release date.
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):  June delivery received; next release in August.

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

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 6/30/2011)

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): June delivery received; next release in August.

Product 40 mg/mL; 50 mL bag (NDC 0409-6729-24): June delivery received; next release in August.

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 7/14/2011)

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 August 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.

 

Mitomycin Powder for InjectionNew! (6/24/2011)

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 batches as they become available and is ramping up production to meet the increase in demand.
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 anticipates release within the next six months.

 

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 7/7/2011)

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 September:

 

-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.

 

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 (7/19/2011)

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 demandBaxter 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 0.5mg/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.

 

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.

 

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. 
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 7/19/2011)

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): Delivery received in June; next release in July.
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 available 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.

 

Tamiflu for Oral Suspension (updated 6/30/2011)

Company/ProductsReasonRelated Information
Genentech:
1-800-551-2231

12mg/ml 25 ml (NDC 00004-0810-95)

Increased demandGenentech plans to begin releasing Tamiflu for Oral Suspension in mid July.

 

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.

 

Thyrogen (thyrotropin alfa) injection 1.1mg/vial (updated 7/14/2011)

Company/ProductsReasonRelated Information
Genzyme Corporation
1-800-745-4447		Temporary DelaysA limited supply of Thyrogen was released to the U.S. market in June.  Due to unexpected delays in the release of three lots of Thyrogen, a stock-out is expected in July and will persist until these lots are released.  Temporary shipment delays will then continue to occur for the remainder of 2011 and throughout 2012.

 

Thyrolar Tablets (12/31/2009)

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

 

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 7/19/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797		Increase in demandBedford is allocating vecuronium 20 mg vials and these are available for drop-shipment. Vecuronium 10 mg vials are on back order and no release date is reported.
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 10 mg vial (NDC 0409-1632-01):  Hospira targets return to market in 3rd quarter 2011.

Product 20 mg vial (NDC 0409-1634-01):  Availability to be determined.

 

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#buprenorphine

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