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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
Recall Number D-1344-2014
Classification Class II
Code Info Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
Product Distributed Qty 43,007 Bottles
Reason For Recall Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.

Event Detail

Event Id 68123
Product Type Drugs
Status Ongoing
Recalling Firm SigmaPharm Laboratories LLC
City Bensalem
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico