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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Event Detail

Event ID 62135
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 2011-09-19
Initial Firm Notification of
Consignee or Public
Distribution Pattern NC and KY

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146. Lot #: a) 5NON, Exp 04/13; 5YUN, Exp 09/13; b) 5KBJ, Exp 02/13; 5LVX, Exp 04/13 Class II Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets. a) 4 bottles; b) 2 bottles D-1379-2012