Drug product
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
D-0517-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,344 blisters
- Official record key
drug-enforcement:D-0517-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: 19B011, 19B012, 19B012A, 19E023, Exp. Date 05/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations