Drug product
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.
D-260-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 64835
- Status
- Completed
- Classification
- Class II
- Quantity
- 10121 bottles
- Official record key
drug-enforcement:D-260-2013
Official wording
Reason: Chemical contamination: emission of strong odor after package was opened.
Code information: Lot # a) 67507B, Exp. 02/14; b) 67508B, Exp. 02/14
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination