Drug product
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
D-0046-2024
Product summary
- Event
- Event 93007
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 5,316 bottles
- Official record key
drug-enforcement:D-0046-2024
Official wording
Reason: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Code information: Lot # PA3083011, Exp 3/31/2025
Distribution pattern: Nationwide in the US
Derived failure modes
-
Microbial contamination
Microbial contamination