Exact FDA event identifier

Event 95824

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

Event summary

Timeline bucket: November 22, 2024
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Apothecus Pharmaceutical Corp.

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

VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY 11779, NDC 52925-512-10

D-0151-2025

Recall number: D-0151-2025
Initiated: November 22, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Apothecus Pharmaceutical Corp.
Quantity: 33,659 retail boxes in US

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: out of specifications for assay

Code information

Lot: 3A001/3A001A, Exp: 07/25

Distribution pattern

Nationwide in the USA and 2 Distributors in Hong Kong