Exact FDA event identifier

Event 93007

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 08, 2023
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Church & Dwight Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0046-2024

Recall number: D-0046-2024
Initiated: September 08, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Church & Dwight Inc
Quantity: 5,316 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

Code information

Lot # PA3083011, Exp 3/31/2025

Distribution pattern

Nationwide in the US