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Pharmacist Society Professionals - News Article:
Drug Shortages
3/21/2011 12:00:00 AM

Current Drug Shortages


 

Drug Name Company
Information
Reason for Shortage Related Information

Amikacin Injection

updated
3/17/2011

Teva Pharmaceuticals 1-800-545-8800






 






Bedford Customer Service
1-800-562-4797


 

Manufacturing delays














Manufacturing delays



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

Amino Acid Injection

updated
2/17/2011
 
Hospira Customer Service:
(1-877-946-7747)



Baxter Customer Service:
(1-888-229-0001)
























B Braun Customer Service:
(1-800-227-2862)


 
Commodity shortage





Increase in demand


























Increase in demand
 
Hospira Information (PDF - 15KB)1




Baxter 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)

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
 
Hospira Inc.
1-877-946-7747
 
Supply interruption
 
Hospira 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

Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week. See information in Related Information section.
 

Limited supplies continue to be available.

Please see attached DHP letter for important safety information.

 

Dear Healthcare Professional2

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


12/7/2010
 

Hospira Inc.
1-877-946-7747

Change in manufacturing sites.

Hospira anticipates releasing product sometime in 2011.

Arginine 10% injection (R-Gene 10)

updated
11/30/2010

Pfizer
Customer Service
1-866-485-1359 
Manufacturing delays For additional information see the Dear Health Care Professional Letter (PDF - 143KB)3
Avalide (irbesartan and hydrochlorothiazide)Tablets

updated
1/5/2011
Bristol-Myers Squibb
1-800-321-1335
Manufacturing delays BMS cannot estimate a date of availability.

Bristol-Myers Squibb Medical Information Online4



 

Bleomycin Injection

updated
1/12/2011
 

APP
1-888-386-1300
15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20)
 




Teva Pharmaceuticals 1-800-545-8800






Bedford
1-800-562-4797
15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01)


Hospira
1-877-946-7747
15 unit vial (NDC 61703-0332-18)
30 unit vial (NDC 61703-0323-22)
 

 

 

 

Increased demand





 





Manufacturing delays




 



Manufacturing delays






 

Manufacturing delays

 

 

 

APP 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.


15 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 has bleomycin 15 and 30 unit vials on long term back order with no release date.



 

Backordered until 1Q 2011.

 

Bumetanide Injection

updated
3/17/2011

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

0.25 mg.mL; 10 mL vial
NDC 0409-1412-10
0.25 mg.mL; 10 mL Novaplus vial

NDC 0409-1412-50


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

 

0.25mg/ml

2 ml vial 55390-0500-02

4 ml vial 55390-0500-05

10 ml vial 55390-0500-10


 
Hospira
1-877-946-7747


















Baxter
1-888-229-0001



Bedford
1-800-562-4797



 

Increased demand



















Increased demand
 



Increased Demand
 

Hospira 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 has all bumetanide 0.25 mg/mL injections on back order.

Bedford 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

 

updated
9/9/2010

Hospira Inc.
1-877-946-7747

 

 








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

 

 









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

Unanticipated Increased Demand

Hospira 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. 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 (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
3/17/2011
 

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)



















Luitpold
631-924-4000

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

 

Increase in demand




























Increase in demand
 
APP 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.

American Regent/Luitpold has available calcium gluconate 100 mg/mL 50 mL (NDC 00517-03950-25), and 100 mL (NDC 00517-3900-25) vials. The 100 mg/mL 10 mL (NDC 00517-3910-25) vials are discontinued.
 

Cisplatin injection 1 mg/mL solution

 



updated
9/1/2010

APP
1-888-386-1300








Teva Pharmaceuticals
1-800-545-8800









Bedford
1-800-562-4797
 
Increased demand.









Manufacturing delays










Manufacturing delays




 

APP 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 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.


Cisplatin 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

The Medicines Company See Related Information Section Please visit: Recall -- Firm Press Release5 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)

updated
3/17/2011














(Solution) 

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)


APP
1-888-386-1300
100 mg/mL, 20 mL vial (NDC 63323-0120-20)


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)
 

Manufacturing delays







 




Manufacturing delays

 





API shortage/manufacturing delay
 

Bedford has all cytarabine presentations on back order.

 







APP anticipates a release of the 2 gram vials in 2Q 2011.





Hospira plans on releases of the 20mg/ml 50 ml and 20mg/ml 5 ml vials in March.  The 20mg/ml 25ml vials in April. The release date of the 100mg/ml 20ml vials to be determined.

Desmopressin injection

 

updated
2/1/2011

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)


Hospira Inc. 
1-877-946-7747
(4 mcg/mL, 1 mL amp (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))

 

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))

n/a









Increased demand/manufacturing delays




Unanticipated increased demand



 



Manufacturing delays
 

 

 

Ferring is continuing to release product as soon as it becomes available.

 






Hospira has available desmopressin 4 mcg/mL 1 mL vials (NDC 00409-2265-01).




Sanofi is continuing to release product as soon as it becomes available.





Teva 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.
 

Doxorubicin (adriamycin) lyophilized powder



10 mg vials (NDC 55390-0231-01)

20 mg vials (NDC 55390-0232-10)

50 mg vial (NDC 55390-0233-01)


updated
2/1/2011
 


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

Doxorubicin Solution for Injection

updated
3/17/2011
 

APP
1-888-386-1300
APP Product Availability Information6

 






Teva Pharmaceuticals
 1-800-545-8800












Bedford
1-800-562-4797

 

 

Increased demand










Manufacturing delays



 










Increased demand

APP 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 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 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


updated
12/22/2010
 

Hospira Inc.
1-877-946-7747

Manufacturing delays

Hospira anticipates releasing 500 mg Add-Vantage (NDC 0409-6476-44) and 500 mg vial
NDC (0409-6482-01) in 1Q2011.

Ethiodol (ETHIODIZED OIL) ampules

 

updated
12/10/2010

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)7 for additional information.
(Letter updated 12/10/2010)

Etoposide solution for injection


updated
2/1/2011
 

Bedford
1-800-562-4797

 






Teva Pharmaceuticals
1-800-545-8800



 





APP
1-888-386-1300






BMS Customer Service
1-800-426-7644

Increased demand

 





 


Manufacturing delays



 






Manufacturing delays

 






Increased demand
 

Bedford is releasing all etoposide solution for injection 20 mg/mL presentations as they become available.


 

Teva 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 is releasing all etoposide solution for injection 20 mg/mL presentations as they become available.


 

BMS has available Etopophos 100 mg powder for injection (NDC 00015-3404-20).
 

Fabrazyme (agalsidase beta)


updated
2/2/2011

Genzyme Corporation

 

For inquiries contact Genzyme Medical Information: medinfo@genzyme.com or 800-745-4447, option 2

 

Manufacturing delays

 

Please see Dear Doctor Letter (PDF - 395KB)8 for additional information.

Visit Web site: Genzyme supply update9

 

Foscarnet sodium 24 mg/mL injection


updated

9/27/2010

Hospira, Inc. Manufacturing delays Hospira 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)10 for information about emergency supplies that are now available from Clinigen to help address the shortage.


 

Fosphenytoin Sodium Injection

 

updated
2/1/2011

Bedford Laboratories
1-800-562-4797

 

Hospira
1-877-946-7747

 


Akorn Pharmaceuticals
1-800-932-5676



APP
1-888-386-1300


 

West-Ward Pharmaceuticals
Customer Service:
1-800-631-2174



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


 

Not currently marketed

 


Manufacturing delays

 


Not currently marketed

 


Increase in demand




Increased demand







Newly launched product 

Bedford will be off the market for an undefined period of time.

 

Supply Information for Hospira (PDF - 15KB)11

 

Akorn will be off the market for an undefined period of time.

 

APP continues to release product as it becomes available.


West-Ward has available NDC# 0143-9788-25 fosphenytoin 150 mg/2ml and NDC# 0143-9782-10 fosphenytoin 750 mg/10 ml.

American Regent  has available fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25).
 

Furosemide Injection 10mg/ml

 

 

updated
12/27/2010

Hospira Inc.
1-877-946-7747

 

 

















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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APP
1-888-386-1300

Manufacturing delays

 

 

 

















Increase in demand

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Increase in demand

Hospira 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., 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 user.
 
APP 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
2/1/2011

Teva Pharmaceuticals
1-800-545-8800



Ortho-McNeil Janssen
1-800-526-7736

 

 

 




APP Pharmaceuticals
1-888-386-1300

 

 

 

 

 

 

 




Bedford Laboratories Customer Service
1-800-562-4797

 

Manufacturing delays

 

 

See Related Information

 

 

 




See Related Information

 

 

 

 

 

 





Manufacturing delays

Teva has all presentations on back order.
 

Ortho-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 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 has all haloperidol decanoate presentations on long term back order.

Intravenous Fat Emulsion

 

updated
1/19/2011

Hospira (Liposyn III Emulsion)
Customer Service:
1-877-946-7747)

 

 

 

 

 

 

 

 

 

 


Baxter (Intralipid Emulsion)
Customer Service:
(1-888-229-0001)

 

Manufacturing issues

 

 

 

 

 

 

 

 

 

 

 

 

 

Baxter now has adequate supply available to meet demand.

Hospira 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 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
2/1/2011

 

 

 

 

 

 

 

 

 

 












Levoleucovorin (Fusilev) 50 mg single use vials


updated
3/7/2011

Bedford Laboratories
Customer Service
1-800-562-4797

 

 

 

 

 


Teva Pharmaceuticals
1-800-545-8800


 





APP Pharmaceuticals 1-888-386-1300
 

 

 

 






Spectrum Pharmaceuticals
1-877-387-4538 or
1-877-FUSILEV
 

Manufacturing delays

 

 

 

 

 

 

 

Manufacturing delays



 





APP has recently launched their leucovorin injection in response to the ongoing shortage.
 

 

 

 



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)12 for additional information.

 

Bedford 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 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 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).
 

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 Pharmaceuticals13Exit Disclaimer14 web site.

Levorphanol 2mg Tablets

 

updated
12/3/2010

Roxane Laboratories
1-614-276-4000
Manufacturing delays.

Product anticipated to be available soon.

Metoclopramide injection


2/4/2011

Baxter Customer Service:
(1-888-229-0001)
5 mg/mL, 2 mL vial, 25 count (NDC 10019-0450-02)
 






Hospira Inc.
1-877-946-7747
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)

 

 

 

 

Increased Demand




 








Hospira discontinued metoclopramide ampules in February, 2010, and Carpuject syringes in May, 2009.





 

Baxter 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 has available metoclopramide injection 5 mg/mL 2 mL vials (NDC 00409-3414-01).




Teva has made a business decision to discontinue this product. See the Dear Valued Customer Letter (PDF - 32KB)15
 

Mexiletine Capsules (150mg, 200mg, and 250mg)

 

 

updated
9/24/2010

Teva Pharmaceuticals
1-800-545-8800
Manufacturing Delays

Teva 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.

Morphine Injection (2 mg, 4 mg, 8 mg, and 10 mg)

updated
2/1/2011


























5 mg/mL, 1 mL vial (NDC 10019-0176-44)

8 mg/mL, 1 mL vial (NDC 10019-0177-44)

10 mg/mL, 1 mL vial (NDC 10019-0178-44)

10 mg/mL, 1 mL ampule (NDC 10019-0178-68)

15 mg/mL, 1 mL vial (NDC 10019-0179-44)
15 mg/mL, 20 mL vial (NDC 10019-179-63)


 
Hospira
1-877-946-7747






























Baxter
1-888-229-0001





















Amphastar
1-800-423-4136

 
Manufacturing delays































Increased demand






















Manufacturing delays

 
Hospira reports they are releasing via emergency shipments the 2 mg/mL, 1 mL Carpujects (NDC 0409-1762-30), the 4 mg/mL, 1 mL Carpujects (NDC 0409-1258-30), the 8 mg/mL, 1 mL Carpuject (NDC 0409-1260-69) and the  10 mg/mL, 1 mL Carpuject(NDC 0409-1261-30) as supplies become available.  The 15 mg Carpujects are available (NDC 00409-1264-31). Hospira has 1 mg/mL, 10 mL vials NDC 00409-3815-12, 25 mg/mL Add-Vantage presentations (4 mL vial NDC 00409-6177-14 and 10 mL vial NDC 00409-6179-14) presentations available and also has the 50 mg/mL vials available (20 mL vial NDC 00409-1134-03, 50 mL vial NDC 00409-1134-05).

Baxter has accelerated production and is releasing morphine injection 5 mg/mL 1 mL vials (NDC 10019-0176-44), 10 mg/mL 1 mL (NDC 10019-0178-44) and 10 mL (NDC 10019-0178-62) vials, and 15 mg/mL 1 mL vials (NDC 10019-0179-44) as well as Infumorph 200 (NDC 60977-0114-01) and Infumorph 500 (NDC 60977-0115-01) and Duramorph preservative-free 0.5 mg/mL 10 mL ampules (NDC 60977-0016-02) and 1 mg/mL 10 mL ampules (NDC 60977-0017-01).

Amphastar now releasing. Amphastar has 1 mg/mL 10 mL syringe (NDC 00548-3391-00).
 

Mustargen (mechlorethamine HCl) injection

 

updated
9/30/2010

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

Lundbeck 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)16 from Lundbeck for additional information.

MVI injectable (Adult and pediatric)

 

updated
5/28/2010

Hospira
1-877-946-7747

 

 

 

 

 

 

Baxter (Infuvite adult and pediatric IV solution)
Customer Service:
1-888-229-0001

Manufacturing delays relative to all adult formulations; Hospira is working to restore adequate supply, however, no timing is available.

 

 

Increase in demand

MVI Pediatric 5mL Single Dose Vial (NDC 61703-421-53): Product is in adequate supply.

 

 

 

Infuvite both adult and pediatric IV solution remains available from Baxter

Nalbuphine Injection

updated
3/17/2011

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 

Hospira
1-877-946-7747
Manufacturing delays

Hospira 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

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

New!
3/7/2011
 
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)


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)




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 demand










Increased demand












Increased demand




 
Both strengths are on backorder with anticipation to have additional supply available in the March-April timeframe.




American Regent project the 0.5 mg/mL 10 mL vials (NDC 00517-0034-25) will be available the first week in April 2011 and the 1 mg/mL 10 mL vials (NDC 00517-0033-25) will be available the first week of March 2011.


The 0.5mg/mL is currently back-ordered with an estimated release in Q2 2011. The 1mg/ml 10 ml (63323-0383-10) vials are currently back-ordered with multiple releases estimated late March.

 

Neupro (rotigotine transdermal system)

updated
5/5/2010

UCB, Inc
800-477-7877
UCB has recalled all domestic lots

FDA 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%

updated
3/17/2011
 

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)






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 delays




 










Manufacturing delays
 

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

Norepinephrine Bitartrate Injection

updated
3/10/2011
 

Bedford Customer Service:
1-800-562-4797
(Bedford 4 mL vial, package of 10 (NDC 55390-0002-10))


 

Hospira Inc.
1-877-946-7747
(NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04)

 

 








Teva Pharmaceuticals 1-800-545-8800
(Teva 4 mL vial, package of 10 (NDC 00703-1153-03))

 

 

Manufacturing delays



 





Increase in demand


 

 

 









Teva temporarily discontinued norepinephrine in June 2010.

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

Levophed (Norepinephrine Bitartrate Injection) 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) are on back order, and the company expects continuous deliveries going forward, with recovery estimated to occur in 3Q 2011.

 

Teva anticipates having product available again 4th quarter 2011.

Oxsoralen (methoxsalen) 1% topical lotion

 

update
7/6/2010

 

Valeant Pharmaceuticals International
1-866-819-9007

 

Manufacturing delays

 

There is not yet an estimated release date.

 

Oxsoralen-Ultra (methoxsalen) 10 mg capsules

 

updated
6/17/2010

Valeant Pharmaceuticals International
Customer Service
1-800-556-1937

Manufacturing delays

 

Valeant 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)17 for additional information.

You may also contact Valeant by e-mail at pharmcs@valeant.com for additional information.

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

updated
3/17/2011
 

Hospira Inc.
1-877-946-7747

Manufacturing delays

Hospira 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
9/29/2010

 

 

Teva Pharmaceuticals
1-800-545-8800

 

 


Hospira Inc.
1-877-946-7747

 

 

 

APP
1-888-386-1300

Teva Pharmaceuticals has discontinued their propofol injection.

 

Hospira is beginning to release a limited number of batches of propofol. Further delivery information will be forthcoming

 

APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section

Questions and Answers on the Propofol Shortage18

Regonol injection, 5 mg/mL, 2 mL ampules (NDC 00781-3040-95)


2/4/2011

 
Sandoz
1-800-525-8747
 
Manufacturing delays
 
Sandoz has Regonol 5 mg/mL 2 mL ampules on back order. The product is listed as temporarily unavailable and the company cannot estimate a release date.
 
Renacidin Irrigation  NDC# 00327-0011-05


1/27/2011
 
Guardian Laboratories 1-800-645-5566 Manufacturing delays Guardian 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%

updated
3/17/2011
 
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)




American Regent, Inc.
1-800-645-1706
30 mL vials (NDC 00517-2930-25), 100 mL vials (NDC 00517-2900-25)







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)


 
Increased demand










Increase in demand












Manufacturing delays

 

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

 

Sodium Chloride 14.6% Injection

updated
3/17/2011
 
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)


APP
1-888-386-1300
14.6%, 20 mL vials (NDC 63323-0139-20), 40 mL vials (NDC 63323-0139-40)
 

Increase in demand



 




Increased demand

 

Hospira plans to release by end of March, 2011.





APP does not yet have a release date. 

Succinylcholine injection


updated
2/1/2011
 

Sandoz
1-800-525-8747
 



Hospira
1-877-946-7747
 

Increased demand





Manufacturing delays
 
Sandoz reports weekly releases are occurring for Anectine 20 mg/mL 10 mL vials (NDC 00781-3009-95)

Hospira 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)

 

 

updated
8/5/2010

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
 
Genentech: Product support and fulfillment: 1-800-551-2231

For medical information:
1-800-821-8590
Increased demand Genentech 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: Tamiflu19disclaimer icon20

Thyroid (desiccated) tablets

 

2/12/2010

Forest
RLC
Forest 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

Forest Pharmaceuticals Manufacturing delays Forest has not yet reported when Thyrolar will be available.

Tromethamine 500 mL Injection, NDC 0409-1593-04


10/22/2010
 

Hospira Inc.
1-877-946-7747

Manufacturing delays

Hospira anticipates next product release 1Q 2011.

Vecuronium Injection

 

updated
2/1/2011

Bedford Laboratories Customer Service
1-800-562-4797

 


Sun Pharmaceutical Industries, Inc.
1-800-818-4555

 

 

 

 

 









Teva Pharmaceuticals
1-800-545-8800

 

 

 

 

Hospira, Inc.
1-877-946-7747

Increase in demand

 

 



Increase in demand

 

 

 

 













On manufacturing hold

 

 

 



Manufacturing Delays

Bedford has vecuronium 20 mg vials (NDC 55390-0039-10) available.

 

Sun 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 has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder.

 

Hospira will be off-market for an undefined period.

 

    

 
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Related Information

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