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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

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

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 Letter
Distribution Pattern Nationwide.