Food product
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
F-0722-2022
Product summary
- Event
- Event 89512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26,682,419 tablets
- Official record key
food-enforcement:F-0722-2022
Official wording
Reason: cGMP Deviations
Code information: Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046
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