Drug Enforcement D-251-2013

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 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
Product quantity
23210 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-251-2013
Event ID
64835
Recall initiation date
March 28, 2013
Center classification date
April 18, 2013
Code info
Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14
More code info
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