Drug product
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
D-1397-2012
Product summary
- Event
- Event 61776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100,761 cartons
- Official record key
drug-enforcement:D-1397-2012
Official wording
Reason: Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
Code information: Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.