MAPLE GROVE, Minn., Feb. 18, 2011 /PRNewswire/ -- 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 single 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 (100-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 |
