Drug product
Lloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
D-443-2013
Product summary
- Event
- Event 65154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,768,782 tablets
- Official record key
drug-enforcement:D-443-2013
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 #: HC29411, Exp May-13; HD00512, Exp Jul-13; HA08912, Exp Oct-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