Drug product
Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
D-0479-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,776 blisters
- Official record key
drug-enforcement:D-0479-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: 19E058A, 19E058B, Exp. Date 05/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations