Drug product
Levoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
D-423-2013
Product summary
- Event
- Event 65172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 194,142 bottles
- Official record key
drug-enforcement:D-423-2013
Official wording
Reason: Subpotent Drug: The products were below specification for potency at the expiry stability point.
Code information: Lot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent