Drug Enforcement D-431-2013

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

Status

Terminated

Classification

Class II

Report Date

May 29, 2013

Termination Date

June 30, 2016

Product Information

Product description
Levoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Product quantity
33,227 bottles
Reason for recall
Subpotent Drug: The products were below specification for potency at the expiry stability point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Puerto Rico

Location & Firm

Recalling firm
King Legacy, a wholly owned subsidiary of Pfizer
Address
501 5th Street, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-431-2013
Event ID
65172
Recall initiation date
April 30, 2013
Center classification date
May 20, 2013
Code info
Lot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13
More code info
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