Upsher-Smith Laboratories announced a nationwide voluntary recall of Jantoven (warfarin sodium) 3mg tablets with an expiration date of September 2012, Lot #284081, NDC #0832-1214-00. This recall was initiated after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain 10mg-strength tablets, before it was dispensed. To date, Upsher-Smith has identified no additional mislabeled bottles.
The two Jantoven dosage strengths can be readily differentiated by color: the 3mg tablet is tan and the 10mg tablet is white. Additionally, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line.
Jantoven is an anticoagulant indicated for the treatment of thromboembolic disorders; thromboembolic complications from atrial fibrillation, cardiac valve replacement; and for the reduction of risk of death, recurrent MIs, and thromboembolic events post-MI.
For more information call (888) 650-3789 or visit www.upsher-smith.com.