Church & Dwight Inc: Drug Recall

Recall #D-0046-2024 · 09/08/2023

Class I: Dangerous

Recall Details

Recall Number
D-0046-2024
Classification
Class I
Product Type
Drug
Recalling Firm
Church & Dwight Inc
Status
Ongoing
Date Initiated
09/08/2023
Location
Princeton, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,316 bottles

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

Distribution Pattern

Nationwide in the US

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.