FDA recall D-0902-2017

Safecor Health, LLC · Class II · drug

Product

Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

Reason for recall

CGMP Deviations

Distribution

MA and NY

Key facts

Status
Terminated
Initiation date
2016-07-07
Report date
2017-06-21
Termination date
2017-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woburn, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0902-2017