PlainRecalls
FDA Drug Critical Class I Ongoing

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

Reported: October 25, 2023 Initiated: September 8, 2023 #D-0046-2024

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

Reason for Recall

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

Details

Recalling Firm
Church & Dwight Inc
Units Affected
5,316 bottles
Distribution
Nationwide in the US
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Church & Dwight Inc. Units affected: 5,316 bottles.
Why was this product recalled?
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Which agency issued this recall?
This recall was issued by the FDA Drug on October 25, 2023. Severity: Critical. Recall number: D-0046-2024.