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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

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.
Recall Number D-091-2013
Classification Class III
Code Info Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12
Product Distributed Qty 9 bottles
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.

Event Detail

Event Id 62924
Product Type Drugs
Status Completed
Recalling Firm Physicians Total Care, Inc.
City Tulsa
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-04-08
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern VA
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