Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3-mg Tablets.
The expanded recall now includes 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.
The substitution of warfarin, or any other product, may lead to a change in the therapeutic effect of the intended drug.
Because 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 |
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).
