Drug product
Mint Flavored Antacid (Calcium Carbonate 420mg) 2 tablet packets, Mfg for Just American Safety, Osceola, IN 46561, NDC 67060-303-68
D-0496-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,309,800 packets
- Official record key
drug-enforcement:D-0496-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9523, K9523 Exp. Date 03/2022; AK9670, Exp. Date 06/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations