FDA added to recall for Coumadin plus 7 other medications

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FDA added to recall for Coumadin plus 7 other medications

Postby dlcnurse » Thu Feb 24, 2011 12:00 am

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 (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.htm1
Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
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 http://www.upsher-smith.com3.

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