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-430-2013
Product summary
- Event
- Event 65172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 51,438 bottles
- Official record key
drug-enforcement:D-430-2013
Official wording
Reason: Subpotent Drug: The products were below specification for potency at the expiry stability point.
Code information: Lot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent