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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 62911
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and PR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01 Lot: 3018952, Exp 08/12 Class III Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing. 31,867 Bottles D-1703-2012