Drug recall
TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles…
FDA recall event 93007 · Class I · Church & Dwight Inc
Key facts
| Event ID | 93007 |
|---|---|
| Recall numbers | D-0046-2024 |
| Recalling firm | Church & Dwight Inc |
| Product type | Drugs |
| Products | 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… |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis |
| Initiation date | Sep 8, 2023 |
| Report date | Oct 25, 2023 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 2280705 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: