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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Recall Number D-318-2013
Classification Class III
Code Info 12K714 exp. 12/13, 12K715 exp. 12/13
Product Distributed Qty 21,667 bottles
Reason For Recall Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing.

Event Detail

Event Id 64729
Product Type Drugs
Status Ongoing
Recalling Firm L. Perrigo Co.
City Allegan
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-12
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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