Drug product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
D-091-2013
Product summary
- Event
- Event 62924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9 bottles
- Official record key
drug-enforcement:D-091-2013
Official wording
Reason: Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Code information: Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12
Distribution pattern: VA
Derived failure modes
-
Potency or specification failure
Subpotent