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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64835
Product Type Drugs
Status Ongoing
Recalling Firm Pfizer Inc.
City New York
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-28
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and PR

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14 Class II Chemical contamination: emission of strong odor after package was opened. 29613 bottles D-252-2013
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. Lot # a) 66675B, Exp. 10/13; b) 66852B Exp. 10/13; 67138B, Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened.. 23210 bottles D-251-2013
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. Lot # a) 66671B, Exp. 11/13; 67512B, Exp. 02/14 b) 66739B Exp. 11/13; 67513B Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened. 14464 bottles D-261-2013
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14 Class II Chemical contamination: emission of strong odor after package was opened. 10121 bottles D-260-2013
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66375B, Exp. 10/13; 66719B, Exp. 01/14; b) 66904B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened. 36045 bottles D-259-2013
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened. 7901 bottles D-258-2013
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14 Class II Chemical contamination: emission of strong odor after package was opened 37891 bottles D-257-2013
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 67343B, Exp. 01/14; b) 66902B, Exp. 12/13 Class II Chemical contamination: emission of strong odor after package was opened. 9213 bottles D-256-2013
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. Lot # a) 66897B, Exp. 12/13; b) 67137B, Exp.02/14 Class II Chemical contamination: emission of strong odor after package was opened.. 18195 bottles D-255-2013
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66619B, Exp. 11/13; 67010B, Exp. 01/14; b) 66733B, Exp. 11/13; 67441B, Exp. 01/14 Class II Chemical contamination: emission of strong odor after package was opened.. 26447 bottles D-254-2013
Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. Lot # a) 66369B, Exp. 10/13; 66679B, Exp. 11/13; 66850B, Exp. 12/13; b) 66676B, 66732B, Exp. 12/13; 67136B, Exp. 03/14 Class II Chemical contamination: emission of strong odor after package was opened. 37809 bottles D-253-2013
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