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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 Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Recall Number D-428-2013
Classification Class II
Code Info Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
Product Distributed Qty 77,272 bottles
Reason For Recall Subpotent Drug: The products were below specification for potency at the expiry stability point.

Event Detail

Event Id 65172
Product Type Drugs
Status Ongoing
Recalling Firm King Legacy, a wholly owned subsidiary of Pfizer
City Bristol
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico