Drug product
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.
D-258-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 64835
- Status
- Completed
- Classification
- Class II
- Quantity
- 7901 bottles
- Official record key
drug-enforcement:D-258-2013
Official wording
Reason: Chemical contamination: emission of strong odor after package was opened.
Code information: Lot # a) 67013B, Exp. 01/14; b) 66900B, Exp. 01/14
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination