Drug product
Levothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01.
D-448-2013
Product summary
- Event
- Event 65154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,911 Bottles
- Official record key
drug-enforcement:D-448-2013
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 #: 1096372, Exp May-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