Drug product
Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
D-085-2013
Product summary
- Event
- Event 62511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,443/100-tablet bottles
- Official record key
drug-enforcement:D-085-2013
Official wording
Reason: cGMP Deviations; does not meet in process specification requirements
Code information: Lot #1097178 exp. 7/31/2013
Distribution pattern: Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations