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Upsher-Smith Expands Recall

By Pharmaceutical Processing | February 23, 2011

Upsher-Smith Labs 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.

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 (90-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.

 

  • Online: http://www.fda.gov/medwatch/report.htm9
  • Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178

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