Exact FDA event identifier

Event 62574

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

Event summary

Timeline bucket: April 30, 2012
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

Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9

D-1439-2012

Recall number: D-1439-2012
Initiated: April 30, 2012
Classification: Class II
Status: Terminated
Recalling firm: Apotex Inc.
Quantity: 119,794 Bottles

App-derived interpretation

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

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.

Code information

Lot #s: JN1060, JN1061, JN1062, Exp 06/12

Distribution pattern

Nationwide and Puerto Rico