Drug product
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.
D-252-2013
Product summary
- Firm
- Pfizer Inc.
- Event
- Event 64835
- Status
- Completed
- Classification
- Class II
- Quantity
- 29613 bottles
- Official record key
drug-enforcement:D-252-2013
Official wording
Reason: Chemical contamination: emission of strong odor after package was opened.
Code information: Lot # a) 66730B, 66853B, Exp. 01/14; b) 66731B, 67116B, Exp. 11/13, 66856B, Exp. 12/13; 67341B, Exp, 02/14
Distribution pattern: Nationwide and PR
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination