Exact FDA event identifier

Event 98536

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

Event summary

Timeline bucket: March 05, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Apotex Corp.

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

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.

D-0407-2026

Recall number: D-0407-2026
Initiated: March 05, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Apotex Corp.
Quantity: 107,136 vials

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

Code information

Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027

Distribution pattern

U.S. Nationwide