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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84289

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

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Event summary

Timeline bucket
November 25, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
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

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 Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.

D-0623-2020
Recall number
D-0623-2020
Initiated
November 25, 2019
Classification
Class III
Status
Terminated
Quantity
a) 34,417 cans b)142 cases 5,112 cans

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable

Code information

Lot # 31560, 31561 exp. date 06/2021

Distribution pattern

Nationwide in the US and Canada