Drug product
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
D-0516-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 308,928 blisters b) 29,808 blisters
- Official record key
drug-enforcement:D-0516-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: a) 19B050A, 19B050B, 19B050C, 19B050D, 19B050E, Exp. Date 06/2022; 19F063, 19F063A, 19F063B, Exp. Date 08/2022; b) 19B050-A, Exp. Date 06/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations