FDA recall D-0514-2022
Ultra Seal Corporation · Class II · drug
Product
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Reason for recall
cGMP deviations
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-24
- Report date
- 2022-02-09
- Termination date
- 2023-10-16
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- New Paltz, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0514-2022