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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84498

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

Open FDA event record

Event summary

Timeline bucket
December 02, 2019
Product types
Drug
Classifications
Class III
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

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%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.

D-0789-2020
Recall number
D-0789-2020
Initiated
December 02, 2019
Classification
Class III
Status
Terminated
Recalling firm
AuroMedics Pharma LLC
Quantity
100,080 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.

Code information

Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.

Distribution pattern

Nationwide in the U.S.