Food product
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
F-0728-2022
Product summary
- Event
- Event 89512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,478,344 tablets
- Official record key
food-enforcement:F-0728-2022
Official wording
Reason: cGMP Deviations
Code information: Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023
Distribution pattern: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations