FDA recall D-0540-2022
ULTRAtab Laboratories, Inc. · Class II · drug
Product
Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
Reason for recall
CGMP Deviations
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
Key facts
- Status
- Terminated
- Initiation date
- 2022-01-26
- Report date
- 2022-02-16
- Termination date
- 2025-01-07
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Highland, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2022