Status
Ongoing
Drug Enforcement D-0046-2024
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Classification
Class I
Report Date
October 25, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 5,316 bottles
- Reason for recall
- Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- Church & Dwight Inc
- Address
-
469 N Harrison St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0046-2024
- Event ID
- 93007
- Recall initiation date
- September 8, 2023
- Center classification date
- October 16, 2023
- Code info
- Lot # PA3083011, Exp 3/31/2025
- More code info
- —