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Safety

Recall -- Firm Press Release

 

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Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin

 

Contact:
Elizabeth Likly
Kovak-Likly Communications
203-762-8833
elikly@klcpr.com

 

FOR IMMEDIATE RELEASE - February 18, 2011 - Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.

At Upsher-Smith, patient safety is of foremost concern. The substitution of warfarin, or any other product, may lead to a change in the therapeutic effect of the intended drug.

Consistent, continuous dosing of any product is necessary for optimal care for many ill patients. Patients should check with their health care provider regarding the appropriateness of their current therapy prior to making any change.

The expanded recall includes the following products:

Product
Batch Number
Expiration Date
Product Identification
Amantadine 100 mg (100-ct bottles)
284166
Aug-12
Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles)
280603
Jul-12
Peach; imprinted AMT, 832
Amantadine 100 mg (100-ct bottles)
283797
Jul-12
Peach; imprinted AMT, 832
 
 
 
 
Amlodipine 5 mg (90-ct bottles)
280564
May-12
White; scored; imprinted ALP, 5, 832
Amlodipine 5 mg (90-ct bottles)
282661
Aug-12
White; scored; imprinted ALP, 5, 832
 
 
 
 
Androxy 10 mg (100-ct bottles)
283336
Sep-12
Green; scored; imprinted 86, 832
 
 
 
 
Baclofen 10 mg (90-ct bottles)
284651
Sep-12
White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (90-ct bottles)
282346
Aug-12
White; scored; imprinted BAC, 10, 832
Baclofen 10 mg (100-ct bottles)
281664
Aug-12
White; scored; imprinted BAC, 10, 832
 
 
 
 
Bethanechol 5 mg (100-ct bottles)
282255
Aug-12
White; scored; imprinted BCL, 5, 832
Bethanechol 10 mg (100-ct bottles)
280569
Jun-12
White; scored; imprinted BCL, 10, 832
Bethanechol 25 mg (100-ct bottles)
280567
Jun-12
Yellow; scored; imprinted BCL, 25, 832
 
 
 
 
Jantoven 1 mg (100-ct bottles)
280617
Mar-12
Pink; scored; imprinted WRF, 1, 832
Jantoven 1 mg (100-ct bottles)
282872
Jul-12
Pink; scored; imprinted WRF, 1, 832
Jantoven 2 mg (100-ct bottles)
280598
Jun-12
Lavender; scored; imprinted WRF, 2, 832
Jantoven 2.5 mg (100-ct bottles)
281667
Jul-12
Green; scored; imprinted WRF, 2 ½, 832
Jantoven 3 mg (100-ct bottles)
280612
Jun-12
Tan; scored; imprinted WRF, 3, 832
Jantoven 3 mg (100-ct bottles)
284081
Sep-12
Tan; scored; imprinted WRF, 3, 832
Jantoven 4 mg (100-ct bottles)
283334
Jul-12
Blue; scored; imprinted WRF, 4, 832
Jantoven 5 mg (100-ct bottles)
280581
Jun-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283340
Jul-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283459
Sep-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 5 mg (100-ct bottles)
283455
Jun-12
Peach; scored; imprinted WRF, 5, 832
Jantoven 6 mg (100-ct bottles)
282277
Jun-12
Teal; scored; imprinted WRF, 6, 832
Jantoven 6 mg (100-ct bottles)
284079
Sep-12
Teal; scored; imprinted WRF, 6, 832
Jantoven 7.5 mg (100-ct bottles)
280614
Aug-12
Yellow; scored; imprinted WRF, 7 ½,
 832
Jantoven 10 mg (100-ct bottles)
283342
Aug-12
White; scored; imprinted WRF, 10, 832
Jantoven 10 mg (100-ct bottles)
282917
Feb-12
White; scored; imprinted WRF, 10, 832
 
 
 
 
Oxybutynin 5 mg (100-ct bottles)
283368
Jul-13
White; scored; imprinted 38, 832


Upsher-Smith Laboratories is working cooperatively with the U.S. Food and Drug Administration to implement a nationwide recall as quickly and efficiently as possible.

The products affected were distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The company is notifying its pharmacy customers and wholesalers, and arranging for the return of all recalled products. These products were packaged at the Upsher-Smith plant in Plymouth, Minnesota.

Consumers and pharmacists can call 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST).

Any adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a privately held pharmaceutical company that develops, manufactures and markets prescription and over-the-counter products. Upsher-Smith’s product portfolio focuses in the areas of women’s health, dermatology, cardiology, and CNS diseases. Upsher-Smith is headquartered in Maple Grove, Minn. For more information, visit www.upsher-smith.com.

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