D-0046-2024 Class I Ongoing

Recalled by Church & Dwight Inc — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
October 25, 2023
Initiation Date
September 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,316 bottles

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

Distribution Pattern

Nationwide in the US

Code Information

Lot # PA3083011, Exp 3/31/2025