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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79542

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals 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 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.

D-0620-2018
Recall number
D-0620-2018
Initiated
March 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
640,486 vaginal inserts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

Code information

Lot #: a) 33812545A, 33812546A, 33812774A, Exp. 12/2018; 33812775A, Exp. 01/2019; 33812776A, 33812777A, Exp. 05/2019; 33813786A, 33813868A, Exp. 7/2019; 33813974A, 33814058A, Exp. 09/2019; 33814113A, Exp. 01/2019; b) 33812547A, 33813361A,33813676A, Exp. 1/2019

Distribution pattern

Distributed within the United States and Puerto Rico.