Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx on...
FDA Recall #D-091-2013 — Class III — April 8, 2011
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.
Recalling Firm
Physicians Total Care, Inc. — Tulsa, OK
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
9 bottles
Distribution
VA
Code Information
Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated