Apotex Brimonidine/Timolol Ophthalmic Solution Class II Recall
Summary
The FDA announced a Class II recall of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% manufactured by Apotex Corp. The recall (Case No. D-0407-2026) was initiated due to lack of assurance of sterility. The affected product has NDC 60505-0589-1 and was distributed nationwide in the U.S.
What changed
Apotex Corp. initiated a Class II drug recall (D-0407-2026) for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%, 5 mL (NDC 60505-0589-1) due to lack of assurance of sterility. The recall affects product manufactured at the Apotex facility in Weston, FL and distributed nationwide in the U.S.\n\nHealthcare providers should identify any patients who received this medication and advise them to return the product. Pharmacies should check their inventory for the affected NDC and quarantine any remaining stock. Adverse events possibly associated with this product should be reported to FDA MedWatch.
What to do next
- Identify affected product by NDC 60505-0589-1 and quarantine remaining inventory
- Notify patients who received this ophthalmic solution and advise them to return the product
- Report any adverse events possibly associated with this recalled product to FDA MedWatch
Source document (simplified)
Apotex Corp.
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0407-2026 · 20260325 · Ongoing
Product
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide
Source: openFDA Enforcement API
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