Drug product
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.
D-257-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 64835
- Status
- Completed
- Classification
- Class II
- Quantity
- 37891 bottles
- Official record key
drug-enforcement:D-257-2013
Official wording
Reason: Chemical contamination: emission of strong odor after package was opened
Code information: Lot # a) 66373B, Exp. 10/13; 66851B, Exp. 12/13; b)66792B, Exp. 12/13; 67349B, Exp. 03/14
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination