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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 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 54868-6164-1. 62QJ, Exp 12/11 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. 5 bottles D-090-2013
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. Lot #: 62QI, Exp 01/12; 6DYQ, Exp 08/12 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. 9 bottles D-091-2013
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. Lot # 62QH, Exp 4/12 Class III Subpotent (Single ingredient) drug : This is a sub recall of Teva's Enjuvia due to low Out of Specification (OOS) assay results. 5 Bottles D-092-2013
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