Drug recall D-425-2013

Class II Terminated reported May 29, 2013

Product

Levoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Reason for recall

Subpotent Drug: The products were below specification for potency at the expiry stability point.

Lots and codes

Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13

Recall details

Recalling firm
King Legacy, a wholly owned subsidiary of Pfizer, Bristol, TN
Quantity
195,201 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
April 30, 2013
Terminated
June 30, 2016

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