D-091-2013 Class III Terminated

Recalled by Physicians Total Care, Inc. — Tulsa, OK

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
9 bottles

Product Description

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.

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 #: 62QI, Exp 01/12; 6DYQ, Exp 08/12