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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86405

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

Open FDA event record

Event summary

Timeline bucket
September 02, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
pH-D Feminine Health

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

pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.

D-1627-2020
Recall number
D-1627-2020
Initiated
September 02, 2020
Classification
Class II
Status
Terminated
Recalling firm
pH-D Feminine Health
Quantity
a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed without an Approved NDA/ANDA.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA.

Code information

Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.

Distribution pattern

Nationwide in the U.S.