FDA recall D-0059-2025

Safecor Health, LLC · Class II · drug

Product

Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01

Reason for recall

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Distribution

USA nationwide.

Key facts

Status
Ongoing
Initiation date
2024-11-11
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0059-2025