FDA recall D-0451-2023

Product

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA Direct LLC, Broadview, IL 60155

Reason for recall

CGMP DEVIATIONS

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2023-02-24

Report date

2023-03-15

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norwalk, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0451-2023