Wednesday, February 23, 2011

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

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:

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