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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Event Detail

Event ID 67399
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Pharmaceuticals Inc.
City Morgantown
State WV
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Levothyroxine Sodium Tablets, USP, 200 mcg, 100-count bottle, Rx only, Distributed by Mylan Pharmaceuticals Inc. Morgantown, WV 26505, NDC 0378-1819-01 Lot 3037531 EXP 03/14 Lot 3038284 EXP 04/14 Class II Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification. 138,970 bottles D-1084-2014