Drug product
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
D-0543-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,923,518 tablets
- Official record key
drug-enforcement:D-0543-2022
Official wording
Reason: CGMP Deviations
Code information: Product Codes: M312 Bulk Lots: 18J004, 18J005, 18C045, 19C046
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations