Apotex Inc. recalls Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution sold nationwide in the US. The recall cites lack of assurance of sterility due to improper bottle sealing. 151,034 bottles affected. Consumers should stop using the product immediately.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
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Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution is a prescription eye drop used to reduce intraocular pressure in glaucoma or ocular hypertension. Patients rely on timely dosing, often daily.
A lack of sterility could expose patients to eye infections or other complications. Improper sealing led to weight loss anomalies noted in packaging; while weight loss is not a typical indicator of sterility, the primary concern is sterility.
This recall is not described as part of a broader industry pattern.
Consumers may face vision risks and require medical evaluation if exposed to non-sterile drops. Replacements or refunds may be issued through manufacturer channels.
FDA recall page D-0676-2025 and Apotex Corp. communications
Refunds or replacements typically processed within 4-8 weeks after submission
Keep recall notice, receipts, serial numbers, and photos of packaging
Brand: BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION. Manufacturer: Apotex Inc., Richmond Hill, Ontario, Canada. For: Apotex Corp., Weston, FL. NDC 60505-0589-1 (5 mL) and 60505-0589-2 (10 mL). Lot numbers VE0614 and VE0616. Expiration 12/2025 for both lots. Distribution: Nationwide in the United States. Quantity: 151,034 bottles.
No injuries or incidents have been reported in the provided data.
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