Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot # PA3083011, Exp 3/31/2025
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0046-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Sep 8, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 5,316 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Church & Dwight Inc
Original FDA data
Every field from FDA enforcement report D-0046-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93007
- Address
- 469 N Harrison St
- Code information
- Lot # PA3083011, Exp 3/31/2025
- Postal code
- 08540-3510
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0046-2024
- Classification
- Class I
- Recalling firm
- Church & Dwight Inc
- Product quantity
- 5,316 bottles
- Reason for recall
- Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Sep 8, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 16, 2023