Exact FDA event identifier

Event 84308

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

Event summary

Timeline bucket: November 19, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AuroMedics 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

Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99

D-0653-2020

Recall number: D-0653-2020
Initiated: November 19, 2019
Classification: Class II
Status: Terminated
Recalling firm: AuroMedics Pharma LLC
Quantity: Unavailable

App-derived interpretation

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

Foreign Tablets

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..

Code information

Lot #: 19819029A3, Exp. 08/2021

Distribution pattern

Nationwide within the United States