Food product
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
F-0729-2022
Product summary
- Event
- Event 89512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,352,387 tablets
- Official record key
food-enforcement:F-0729-2022
Official wording
Reason: cGMP Deviations
Code information: Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050
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