Drug product
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
D-425-2013
Product summary
- Event
- Event 65172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195,201 bottles
- Official record key
drug-enforcement:D-425-2013
Official wording
Reason: Subpotent Drug: The products were below specification for potency at the expiry stability point.
Code information: Lot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent