Exact FDA event identifier

Event 72341

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

Event summary

Timeline bucket: August 25, 2015
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Apotex 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

Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.

D-0009-2016

Recall number: D-0009-2016
Initiated: August 25, 2015
Classification: Class II
Status: Terminated
Recalling firm: Apotex Inc.
Quantity: 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing

Code information

Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016

Distribution pattern

Nationwide