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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Detail

Product Description Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Recall Number D-077-2013
Classification Class II
Code Info Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
Product Distributed Qty 31,252/100-tablet bottles
Reason For Recall cGMP Deviations; does not meet in process specification requirements

Event Detail

Event Id 62511
Product Type Drugs
Status Ongoing
Recalling Firm Lloyd Inc. of Iowa
City Shenandoah
State IA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-09
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.