Drug product
Levoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
D-428-2013
Product summary
- Event
- Event 65172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77,272 bottles
- Official record key
drug-enforcement:D-428-2013
Official wording
Reason: Subpotent Drug: The products were below specification for potency at the expiry stability point.
Code information: Lot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent