Drug product
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
D-0514-2022
Product summary
- Event
- Event 89464
- Status
- Terminated
- Classification
- Class II
- Quantity
- 409,890 packets
- Official record key
drug-enforcement:D-0514-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: AK9486, Exp. Date 02/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP deviations