Drug product
Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
D-084-2013
Product summary
- Event
- Event 62511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,902,957 tablets
- Official record key
drug-enforcement:D-084-2013
Official wording
Reason: cGMP Deviations; does not meet in process specification requirements
Code information: Lot #HE35311
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