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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Product Detail

Product Description Levothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01
Recall Number D-445-2013
Classification Class II
Code Info Lot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13.
Product Distributed Qty 142,103 Bottles
Reason For Recall cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Event Detail

Event Id 65154
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 2013-04-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.