D-0046-2024 Class I Ongoing
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