← FDA ENFORCEMENT
D-0046-2024Class I

Church & Dwight Inc

Recalling firm
Church & Dwight Inc
Product type
Drug
Status
Ongoing
Report date
2023-10-25
Distribution
Nationwide in the US
Firm state
NJ
Product quantity
5,316 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

Lot # PA3083011, Exp 3/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.