Recall events
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Event 96954
Event summary
Timeline bucket May 28, 2025
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
3 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 3
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-2
D-0494-2025
Recall number D-0494-2025
Initiated May 28, 2025
Classification Class II
Status Ongoing
Quantity 87,840 bottles
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 Batch TZ1236, Exp Date: 11/30/2025
Distribution pattern US Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[16571]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 3
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
D-0495-2025
Recall number D-0495-2025
Initiated May 28, 2025
Classification Class II
Status Ongoing
Quantity 105,456 Bottles
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 Batch VD1654, Exp Date: 06/30/2027
Distribution pattern US Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15194]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 3
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
D-0496-2025
Recall number D-0496-2025
Initiated May 28, 2025
Classification Class II
Status Ongoing
Quantity 6,288 Bottles
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 Batch VC6058, Exp Date: 10/31/2025
Distribution pattern US Nationwide.
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[17443]
FDA event record
· Exact recall-number query on openFDA
