Drug Enforcement D-252-2013

Chemical contamination: emission of strong odor after package was opened.

Status

Completed

Classification

Class II

Report Date

April 24, 2013

Termination Date

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Product Information

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.
Product quantity
29613 bottles
Reason for recall
Chemical contamination: emission of strong odor after package was opened.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide and PR

Location & Firm

Recalling firm
Pfizer Inc.
Address
235 East 42nd Street, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-252-2013
Event ID
64835
Recall initiation date
March 28, 2013
Center classification date
April 18, 2013
Code info
Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14
More code info
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