TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry
Summary
The FDA issued a Class I for TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion) by Church & Dwight Inc. Reason: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis.
Details
Source
Drug Recall
External ID
D-0046-2024
Action Date
2023-10-25
Status
Ongoing
Category
drug
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/Code Info: Lot # PA3083011, Exp 3/31/2025
Quantity Affected: 5,316 bottles
Reason for Recall
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-08
Company
Princeton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Church & Dwight Inc has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Church & Dwight Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Church & Dwight Inc have FDA actions?
Church & Dwight Inc has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0046-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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