Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin
Date of Recall
2011-02-19Recall Details
- 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.htm
- Regular Mail: Use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. 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 www.upsher-smith.com.
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