D-092-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2012
- Initiation Date
- April 8, 2011
- Termination Date
- February 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 Bottles
Product Description
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.
Reason for Recall
Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results.
Distribution Pattern
VA
Code Information
Lot # 62QH, Exp 4/12