Exact FDA event identifier

Event 81729

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

Event summary

Timeline bucket: December 04, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Epic Pharma, LLC

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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 Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01

D-0297-2019

Recall number: D-0297-2019
Initiated: December 04, 2018
Classification: Class II
Status: Terminated
Recalling firm: Epic Pharma, LLC
Quantity: 2976 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

foreign tablet

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.

Code information

Lot #: 18103A, Exp 6/20

Distribution pattern

U.S.A. Nationwide