Exact FDA event identifier

Event 89642

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

Event summary

Timeline bucket: February 17, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Direct Rx

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

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

D-0637-2022

Recall number: D-0637-2022
Initiated: February 17, 2022
Classification: Class II
Status: Terminated
Recalling firm: Direct Rx
Quantity: 44 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed impurities/degradation specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed impurities/degradation specifications

Code information

Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23

Distribution pattern

Florida