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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84071

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

Open FDA event record

Event summary

Timeline bucket
October 22, 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 a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.

D-0156-2020
Recall number
D-0156-2020
Initiated
October 22, 2019
Classification
Class II
Status
Terminated
Quantity
216,840 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

Code information

Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020

Distribution pattern

Nationwide in the USA