Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620

Recall Number: D-422-2013

Firm: King Legacy, a wholly owned subsidiary of Pfizer

Classification: Class II

Status: Terminated

Report Date: 20130529

Initiation Date: 20130430

Termination Date: 20160630

Reason for Recall

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

Product Description

Levoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620