Current Drug Shortages: Digoxin Injection

 Acetylcysteine inhalation solutionNew! (4/22/2011)Company/ProductsReasonRelated InformationHospira Inc.
1-877-946-7747200 mg/mL, 30 mL (NDC 00409-3308-03)Increase in demandHospira has 100 mg/mL 30 mL (NDC 00409-3307-03) vials available. The 200 mg/mL30 mL vials are on back order with an estimated release date of late-April 2011.Roxane Laboratories
1-614-276-4000200 mg/mL, 10 mL (NDC 00054-3028-02), 200 mg/mL, 30 mL (NDC 00054-3026-02)Increase in demandRoxane Labs has available acetylcysteine inhalation solution 100 mg/mL 10 mL (NDC 00054-3027-02) and 30 mL (NDC 00054-3025-02) vials. The 200 mg/mL 10 mL and 30 mL vials are on back order and the company estimates a release date of late-May 2011.American Regent/Luitpold
631-924-4000100 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 3/17/2011)CompanyReasonRelated InformationTeva Pharmaceuticals
1-800-545-8800Manufacturing 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
1-800-562-4797Manufacturing delaysBedford has all presentations of amikacin on a back order and the company cannot estimate a release date.  
Amino Acid Injection (updated 2/17/2011)Company/ProductsReasonRelated InformationHospira Customer Service
1-877-946-7747Commodity shortage
 
Hospira Information (PDF - 15KB)Baxter Customer Service:
1-888-229-0001Increase in demandBaxter has the following bulk pharmacy Amino Acid Injections for compounding on allocation  and is working to increase production to meet US market demand.

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
1-800-227-2862Increase 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, 5 mEq/mL, 20 mL vial (NDC 00409-6043-01) (2/1/2011)

Company/ProductsReasonRelated Information

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

Supply interruptionHospira has ammonium chloride 5 mEq/mL 20 mL vials on back order and the company estimates a release date of 2nd quarter, 2011.

 

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 4/22/2011)

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

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 limitations due to DEA quota and uneven product distribution paterrns.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)

This product is subject to DEA quota limitations.20 mg and 30 mg market availability: approx 4/14/11. All other strengths market availability: approx 4/29/11.
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 procurement quota from DEA to support current market demand.All product strengths other than 25 mg 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 (1/12/2011)

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

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

Increased demandAPP is currently back-ordered on all presentations of Bleomycin for Injection at this time. APP is anticipating batch releases to resume in the first quarter of 2011.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delays15 unit vials (NDC 00703-3154-01) and 30 unit vials (NDC 00703-3155-01) are now available and the company is reviewing orders prior to shipping.
Bedford
1-800-562-4797

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

Manufacturing delaysBedford has bleomycin 15 and 30 unit vials on long term back order with no release date.
Hospira
1-877-946-7747

15 unit vial (NDC 61703-0332-18) 30 unit vial (NDC 61703-0323-22)

Manufacturing delaysBackordered until 1Q 2011.

 

Bumetanide Injection (3/17/2011)

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

NDC and Product Description: 0.25 mg.mL; 4 mL vial NDC 0409-1412-04)
0.25 mg.mL; 4 mL Novaplus vial NDC 0409-1412-49

Increased demandHospira is continuing to release the 0.25 mg/mL; 4 mL vial NDC 0409-1412-04; 0.25 mg/.mL; 4 mL Novaplus vial NDC 0409-1412-49, the 0.25 mg/mL; 10 mL vial NDC 0409-1412-10; 0.25 mg.mL; and the 10 mL Novaplus vial NDC 0409-1412-50 as they become available. Hospira is continuing to produce and release product as it becomes available.
Baxter
1-888-229-0001

NDC 0409-1412-50

10019-506-10, 0.25 mg/mL 10 mL vial
10019-506-45, 0.25 mg/mL 4 mL vial

Increased demandBaxter has all bumetanide 0.25 mg/mL injections on back order.
Bedford
1-800-562-4797

0.25mg/ml
2 ml vial 55390-0500-02
4 ml vial 55390-0500-05
10 ml vial 55390-0500-10

Increased demandBedford has 0.25 mg/mL 4 mL vials (NDC 55390-0500-05) available and plans the 10 mL vials and 2 mL vials to be released by end of March 2011.

 

Calcium Chloride Injection (9/9/2010)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Unanticipated Increased DemandHospira is continuing to release calcium scholride 100 mg/mL Injection 10 mL Ansyr syringes (NDC 00409-1631-10) and 10 mL LifeShield syringes (NDC 00409-4928-34) as they become available.
American Regent, Inc.
1-800-645-1706
 American Regent, Inc. currently has Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial available. Due to increases in demand, American Regent, Inc. may not be able to fill all orders. Contact your wholesaler regarding product availability.
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 (9/1/2010)

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
Manufacturing delaysCisplatin injection 1 mg/mL solution from Bedford are all on back order with no estimated release date.

 

Cleviprex 0.5 mg/mL 50 mL vial (NDC 65293-0002-50) 100 mL vial (NDC 65293-0002-00) (3/22/2010)

Company/ProductsReasonRelated Information
The Medicines CompanySee Related Information SectionPlease visit: Recall -- Firm Press Release regarding recall of certain lots that may contain particulate matter. No information at this time regarding when the product will be available.

 

Cytarabine injection (powder for reconstitution) (4/18/2011)

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 all cytarabine presentations on back order.
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)

API shortage/manufacturing delayHospira will begin releasing additional lots of 100mg/ml 20ml vials on April 11, 2011.

Dear Healthcare Professional Letter (PDF - 75KB)

 

Daunorubicin hydrochloride solution for injection New!(4/26/2011)

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)

Increased demandBedford has Cerubidine 20 mg lyophilized powder for injection on back order and the company cannot estimate a release date. Bedford has all daunorubicin solution for injection presentations on back order and the company cannot estimate a release date.

 

Desmopressin injection (2/1/2011)

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.
1-877-946-7747

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

Increased demand/manufacturing delaysHospira has available desmopressin 4 mcg/mL 1 mL vials (NDC 00409-2265-01).
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 (3/25/2011)

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)
Increased demandAll 4mg/mL Dexamethasone codes are currently on allocation due to increase demand:
4mg/mL-1mL (NDC 63323-165-01), 4mg/mL-5mL (NDC 63323-165-05), 4mg/mL-30mL (NDC 63323-165-30).

The 10mg/mL-1mL ( NDC 63323-506-01) and 10mg/mL-10mL (NDC 63323-516-10) presentations are currently available.

APP is continuing to release the product as it becomes available.

 

Digoxin InjectionNew! (4/22/2011)

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)

GSK has discontinued the manufacturing of this presentation.Pediatric presentation 100 mcg/mL, 1 mL (10s - NDC 00173-0262-10) and 250 mcg/mL, 2 mL (10s - NDC 00173-0260-10) are available.

 

Diltiazem Injection 5 mg/mL (4/14/2011)

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)

Manufacturing delaysHospira will have diltiazem 5 mg/mL 5 mL (NDC 00409-1171-01) and 5mg/ml; 10 mL vials (NDC 00409-1171-02) available late-April. The 100mg/ml ADD-Vantage vials (NDC 00409-4350-03) are on back order with an estimated release date of mid-April, 2011. Emergency supplies of the ADD-Vantage vials are available for direct orders.
Bedford Customer Service
1-800-562-4797

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

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

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

Manufacturing delaysBedford has all diltiazem injection on back order and the company estimates a release date early-April, 2011.

 

Doxorubicin (adriamycin) lyophilized powder (2/1/2011)

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)

Increased demandBedford has available doxorubicin and lyophilized powder 10 mg vials (NDC 553900231-10) and is working to release the other presentations.

 

Doxorubicin Solution for Injection (3/17/2011)

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
Increased demandBedford is releasing the following products as they become available:
Adriamycin solution for injection, 2 mg/mL, 5 mL vial (NDC 55390-0235-10) ; 10 mL vial (NDC 55390-0236-10) 25 mL vial (NDC 55390-0237-01) 100 mL vial (NDC 55390-0238-01)

Doxorubicin solution for injection, 2 mg/mL, Novaplus 25 mL multi-dose vial (NDC 55390-0247-01) Novaplus 100 mL multi-dose vial (NDC 55390-0248-01).

 

Erythromycin lactobionate injection (12/22/2010)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Manufacturing delaysHospira anticipates releasing 500 mg Add-Vantage (NDC 0409-6476-44) and 500 mg vial NDC (0409-6482-01) in 1Q2011.

 

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 (2/1/2011)

Company/ProductsReasonRelated Information
Bedford
1-800-562-4797
Increased demandBedford is releasing all etoposide solution for injection 20 mg/mL presentations as they become available.
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva has Toposar 20 mg/mL solution for injection 5 mL vials (NDC 00703-5653-01) vials availalbe. The 25 mL and 50 mL vials are on back order.
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).

 

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

 

Fentanyl Transdermal System (updated 4/22/2011)

Company/ProductsReasonRelated Information
Ortho-McNeil Janssen
Customer Service:
1-800-526-7736

Duragesic Transdermal System, 50 mcg/hr - 5 count (NDC 50458-0092-05); 75 mcg/hr - 5 count (NDC 50458-0093-05); 100 mcg/hr - 5 count (NDC 50458-0094-05); 12 mcg/hr - 5 count (NDC 50458-0090-05); 25 mcg/hr - 5 count (NDC 50458-0091-05)

Manufacturing issuesTimeframe for return currently unavailable.
Apotex Corp.
Apotex Customer Service:
1-(877)-4-Apotex

50 mcg/hr - 5 count (NDC 60505-7002-2), single (NDC 60505-7002-0); 75 mcg/hr - 5 count (NDC 60505-7003-2)

single (NDC 60505-7003-0); 100 mcg/hr - 5 count (NDC 60505-7004-2), single (NDC 60505-7004-0); 25 mcg/hr - 5 count (NDC 60505-7001-2), single (NDC 60505-7001-0)

N/AAll product available.
Sandoz Customer Service:
1-609-627-8500

50 mcg/hr - 5 count (NDC 00781-7112-55); 75 mcg/hr - 5 count (NDC 00781-7113-55); 100 mcg/hr - 5 count (NDC 00781-7114-55); 25 mcg/hr - 5 count (NDC 00781-7111-55)

Manufacturing issuesTimeframe for return currently unavailable.
Mylan Customer Service:
1-800-796-9526

50 mcg/hr - 5 count (NDC 00378-9122-98); 75 mcg/hr - 5 count (NDC 00378-9123-98); 100 mcg/hr - 5 count (NDC 00378-9124-98); 12 mcg/hr - 5 count (NDC 00378-9119-98); 25 mcg/hr - 5 count (NDC 00378-9121-98)

Not Applicable; Capable of Supplying 100 % of Market DemandAll product available for immediate shipment.
Watson Customer Service:
724-514-1800 or 800-272-5525

50 mcg/hr - 5 count (NDC 00591-3212-72), single (NDC 00591-3212-54); 75 mcg/hr - 5 count (NDC 00591-3213-72), single (NDC 00591-3213-54); 100 mcg/hr - 5 count (NDC 00591-3214-72), single (NDC 00591-3214-54); 25 mcg/hr - 5 count (NDC 00591-3198-72), single (NDC 00591-3198-54)

Novaplus Fentanyl Transdermal System, 50 mcg/hr - 5 count (NDC 00591-3601-72), single (NDC 00591-3601-54); 75 mcg/hr - 5 count (NDC 00591-3602-72), single (NDC 00591-3602-54); 100 mcg/hr - 5 count (NDC 00591-3603-72), single (NDC 00591-3603-54); 25 mcg/hr - 5 count (NDC 00591-3600-72), single (NDC 00591-3600-54)

N/AAll product available.
Actavis Customer Service:
800-432-8534 or fax (973) 993-4300 or E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
N/AAll product available.
Mallinckrodt Inc.
(800) 325-8888

50 mcg/hr (NDC 0406-9050-76); 75 mcg/hr (NDC 0406-9075-76); 100 mcg/hr (NDC 0406-9000-76); 25 mcg/hr (NDC 0406-9025-76)

N/AAll product available.

 

Foscarnet sodium 24 mg/mL injection (9/27/2011)

Company/ProductsReasonRelated Information
Hospira, Inc.Manufacturing delaysHospira is working to resolve the manufacturng delay concerning the 250 mL, package of 12 (NDC 00409-3863-02) and 500 mL, package of 12 (NDC 00409-3863-05) and additional information on availability will be forthcoming.

Please see Dear Healthcare Professional Letter (PDF -1MB) for information about emergency supplies that are now available from Clinigen to help address the shortage.

 

Fosphenytoin Sodium Injection (2/1/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
1-800-562-4797
Not currently marketedBedford will be off the market for an undefined period of time.
Hospira
1-877-946-7747
Manufacturing delaysSupply Information for Hospira (PDF - 15KB)
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 10mg/ml (12/27/2010)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Manufacturing delaysHospira is releasing the 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 bottle (NDC 0409-6102-10). Additional supplies of 10 mg/mL, 4 mL Ansyr syringe (NDC 0409-9631-04) , 10mg/ml 10 ml Ansyr Syringe (NDC 0409-1639-10) will be available in early 2011.
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 (2/1/2011)

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
Manufacturing delaysBedford has all haloperidol decanoate presentations on long term back order.

 

Intravenous Fat Emulsion (1/19/2011)

Company/ProductsReasonRelated Information
Hospira (Liposyn III Emulsion)
Customer Service:
1-877-946-7747
Manufacturing issuesHospira has the following Liposyn III emulsion (soybean oil) products on backorder. Hospira is working with FDA to address the issues that led to the shortage. 10% 250 mL (NDC 00409-9790-02) 10% 500 mL (NDC 00409-9790-03) 20% 250 mL (NDC 00409-9791-02) 20% 500 mL (NDC 00409-9791-03) 30% 500 mL (NDC 00409-6892-03)
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 (2/1/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797
Manufacturing delaysBedford is releasing product as it becomes available - the 50 mg vial (NDC 55390-0051-10) 100 mg vials (NDC 55390-0052-10) .200 mg vial (NDC 55390-0053-01) and 350 mg vial (NDC 55390-0054-10).
Teva Pharmaceuticals
1-800-545-8800
Manufacturing delaysTeva has leucovorin calcium lyophilized powder 100 mg and 350 mg vials on back order and the company does not anticipate release until April 2011.
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 (3/7/2011)

Company/ProductsReasonRelated Information
Spectrum Pharmaceuticals
1-877-387-4538 or 1-877-FUSILEV
Due to the shortage of both leucovorin and levoleucovorin products, the FDA has utilized regulatory enforcement discretion for Spectrum Pharmaceuticals, Inc. to temporarily import levoleucovorin 100 mg Powder for Injection manufactured by Pfizer Inc.

Please see the Dear Healthcare Professional Letter (PDF - 159KB) for additional information.

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 (12/3/2010)

Company/ProductsReasonRelated Information
Roxane Laboratories
1-614-276-4000
Manufacturing delaysProduct anticipated to be available soon.

 

Lorazepam Injection 2 mg/ml (4/14/2011)

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:
1-877-946-7747

2 mg/mL, 1 mL vial (NDC 00409-6778-02), 10 mL vial (NDC 00409-6780-02), 2mg/mL Carpuject Luer Lock Slim-Pak (NDC 0409-1985-30)

4mg/ml, 1mL vial (NDC 0409-6779-02)

Increased demandAll presentations anticipated to be released in mid to late April, 2011. Please note that 2mg/ml 1 mL iSecure prefilled syringes (NDC 00409-1985-05) and 4mg/ml 1mLCarpuject syringes (NDC 0409-1539-31) are temporarily unavailable.

 

Methylphenidate HCl (4/5/2011)

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.
Covidien 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)

API constraintsCurrently experiencing a shortage and expect to have product available again in April 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 demandMinus the 5 mg IR presentation, UCB continues to have remaining presentations and strengths available. 5 mg tablets are expected to be on intermittent backorder until mid-May.
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.

 

Metoclopramide injection (2/4/2011)

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.
1-877-946-7747

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

Hospira discontinued metoclopramide ampules in February, 2010, and Carpuject syringes in May, 2009.Hospira has available metoclopramide injection 5 mg/mL 2 mL vials (NDC 00409-3414-01).
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.

 

MVI injectable (Adult and pediatric) (4/5/2011)

Company/ProductsReasonRelated Information
Hospira
1-877-946-7747
Manufacturing delays relative to all adult formulations; Hospira is working to restore adequate supply, however, no timing is available.MVI Pediatric 5mL Single Dose Vial (NDC 61703-421-53): Product is in adequate supply.
Baxter (Infuvite adult and pediatric IV solution)
Customer Service:
1-888-229-0001
Manufacturing delaysInfuvite is now available for Baxter.

 

Nalbuphine Injection (3/17/2011)

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

Manufacturing delaysHospira has 10 mg/mL 1 mL ampules (NDC 00409-1463-01), and 20 mg/mL 1 mL ampules (NDC 00409-1465-01), 10 mL vials (NDC 00409-1467-01), The 10 mg/mL 10 mL vials are anticipated to be available by end of March, 2011.

 

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 (4/14/2011)

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 is currently allocating Neostigmine 1 mg/mL 10 mL vials due to increased demand. The 0.5 mg/mL 10 mL vials are on back order and the company estimates a release date early-May, 2011.

 

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).

 

Nitroglycerin in Dextrose 5% (3/17/2011)

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

10 mg/100 mL, 250 mL (NDC 00338-1047-02)
20 mg/100 mL, 250 mL (NDC 00338-1049-02)
40 mg/100 mL, 250 mL (NDC 00338-1051-02)

Manufacturing delaysBaxter has premix nitroglycerin 10 mg/100 mL in dextrose 250 mL (NDC 00338-1047-02) and 20 mg/100 mL in dextrose 250 mL (NDC 00338-1049-02) available. The 40 mg/100 mL presentation is anticipated to be released by end of March, 2011.
Hospira Inc.
1-877-946-7747

10 mg/100 mL, 250 mL (NDC 00409-1483-02)
10 mg/100 mL, 500 mL (NDC 00409-1483-03)
20 mg/100 mL, 250 mL (NDC 00409-1482-02)
40 mg/100 mL, 250 mL (NDC 00409-1484-02)

Manufacturing delaysHospira has all premix nitroglycerin in dextrose presentations on back order with no estimated release date at this time.

 

Norepinephrine Bitartrate Injection (updated 4/29/2011)

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

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

Manufacturing delays

Bedford has Norepinephrine Bitartrate Injection 1 mg/mL 4 mL vials on back order and the company cannot estimate a release date.

Hospira Inc.
1-877-946-7747

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

Increase in demandLevophed (Norepinephrine Bitartrate Injection) 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) are available for direct order for customers in dire need, and the company expects continuous deliveries going forward, with recovery estimated to occur in 3Q 2011.

 

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.

 

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 New! (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 New! (4/29/2011)

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.

 

Procainamide HCL Injection, 100mg/ml (NDC# 00409-1902-01) 500mg/ml, (NDC# 00409-1903-01) (3/17/2011)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Manufacturing delaysHospira has available procainamide 500 mg/mL 2 mL vials (NDC 00409-1903-01) and anticipates the 100 mg/mL 10 mL vials to be released by late April.

 

Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (updated 4/22/2011)

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.
1-877-946-7747
Hospira states their 2009 recall has been resolved and they are following FDA recommendations for good manufacturing practices. The company has their 20 mL and 50 mL presentations on intermittent back order due to increased demand and the 100 mL vials are on back order due to the prioritization of the 20mL and 50mL. We expect to be shipping the 100 mL vials to customers in May . All product is being shipped to sole contracted customers at this time. 
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 

 

Renacidin Irrigation NDC# 00327-0011-05 (1/27/2011)

Company/ProductsReasonRelated Information
Guardian Laboratories
1-800-645-5566
Manufacturing delaysGuardian Laboratories has less than a one week supply as of 1/27/11 and continues to allocate product with no back-orders. The planned date of release will be posted once available. Guardian Labs cannot estimate when product will be available.

 

Sodium Chloride 23.4% (3/17/2011)

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 on back order and expects release by end of March The 100 mL vials are on back order and the company cannot estimate a release date.
Hospira Inc.
1-877-946-7747

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

Manufacturing delaysHospira has sodium chloride 23.4% solution in 100 mL and 250 mL bulk glass containers on back order.

 

Sodium Chloride 14.6% Injection (3/17/2011)

Company/ProductsReasonRelated Information
Hospira Inc.
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)

Increased demandHospira plans to release by end of March 2011.
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 injectionNew! (4/29/2011)

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

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

Manufacturing delaysHospira has sodium phosphate injections on back order and the company estimates a release date of June, 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 (2/1/2011)

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
Manufacturing delaysHospira is releasing Quelicin 20 mg/ml 10 mL Vials (NDC 0409-6629-02) and 100 mg/mL, 10 mL Vial (NDC 0409-6970-10) as they become available.

  

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, Bedford 15 mg/mL vial (NDC 55390-0030-10) (4/15/2011)

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

See related information section

FDA awaiting additional information and will post when available.

Adienne, in conjunction with the FDA, is initiating a temporary importation of Thiotepa for injection, to the United States market. Please see 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 500 mL Injection, NDC 0409-1593-04 (10/22/2010)

Company/ProductsReasonRelated Information
Hospira Inc.
1-877-946-7747
Manufacturing delaysHospira anticipates next product release 1Q 2011.

 

Vecuronium Injection (2/1/2011)

Company/ProductsReasonRelated Information
Bedford Laboratories
Customer Service
1-800-562-4797
Increase in demandBedford has vecuronium 20 mg vials (NDC 55390-0039-10) available.
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.
1-877-946-7747
Manufacturing DelaysHospira will be off-market for an undefined period.

 

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).

-

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

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