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
