Exact FDA event identifier

Event 87500

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

Event summary

Timeline bucket: March 19, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: X-Gen Pharmaceuticals Inc.

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

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

D-0328-2021

Recall number: D-0328-2021
Initiated: March 19, 2021
Classification: Class II
Status: Terminated
Recalling firm: X-Gen Pharmaceuticals Inc.
Quantity: 720 100-count (10x10 blister strips)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

Code information

Lot # CFMBX, EXP 9/2022

Distribution pattern

Distributed Nationwide in the USA