FDA-Drug2023-10-25Class I
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
Church & Dwight Inc
Hazard
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Sold states
Nationwide in the US
Affected count
5,316 bottles
Manufactured in
469 N Harrison St, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0046-2024Don't want to check this manually?
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