Drug product
Levothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01.
D-449-2013
Product summary
- Event
- Event 65154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61,347 Bottles
- Official record key
drug-enforcement:D-449-2013
Official wording
Reason: cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Code information: Lot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13.
Distribution pattern: The firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.
Derived failure modes
-
Manufacturing or process control
cGMP deviations