September 2023 FDA Recall Drug by Church & Dwight Inc
D-0046-2024 - Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

This Class I drug recall was voluntarily initiated by Church & Dwight Inc on September 8, 2023 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product; presence of yeast identified as candida parapsilosis. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0046-2024

Reason for Recall
Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
Initiated
09-08-2023
Reported
10-25-2023
Quantity
5,316 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93007
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Church & Dwight Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# PA3083011, Exp 3/31/2025