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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Recall Number D-257-2013
Classification Class II
Code Info Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14
Product Distributed Qty 37891 bottles
Reason For Recall Chemical contamination: emission of strong odor after package was opened

Event Detail

Event Id 64835
Product Type Drugs
Status Ongoing
Recalling Firm Pfizer Inc.
City New York
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and PR