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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83019

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Glenmark Pharmaceuticals Inc., USA

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

Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71

D-1340-2019
Recall number
D-1340-2019
Initiated
June 03, 2019
Classification
Class II
Status
Terminated
Quantity
31,656 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Code information

Lot#: 20180516, Exp 4/30/2020

Distribution pattern

U.S.A. Nationwide