Drug product
Levoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
D-424-2013
Product summary
- Event
- Event 65172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,914 bottles
- Official record key
drug-enforcement:D-424-2013
Official wording
Reason: Subpotent Drug: The products were below specification for potency at the expiry stability point.
Code information: Lot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent