Drug product
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
D-0539-2022
Product summary
- Event
- Event 89334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,349,387 tablets
- Official record key
drug-enforcement:D-0539-2022
Official wording
Reason: CGMP Deviations
Code information: Product Code: M303 Bulk lots: 19C042, 19C043, 19F083; Product Code: M303A Bulk Lot: 19E105
Distribution pattern: Bulk product was distributed to 3 distributors who may have distributed finished product.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations