FDA recall D-0046-2024

Church & Dwight Inc · Class I · drug

Product

TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, NJ 08628

Reason for recall

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Distribution

Nationwide in the US

Key facts

Status: Ongoing
Initiation date: 2023-09-08
Report date: 2023-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0046-2024