Drug product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.9mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6165-1.
D-092-2013
Product summary
- Event
- Event 62924
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5 Bottles
- Official record key
drug-enforcement:D-092-2013
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 # 62QH, Exp 4/12
Distribution pattern: VA
Derived failure modes
-
Potency or specification failure
Subpotent