Eye Medication Recalled for Sterility Assurance and Sealing Issues
Apotex Corp. is recalling 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to improper bottle sealing that compromises sterility assurance. Patients should contact their provider for a replacement.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription ophthalmic medication with sterility assurance defects due to improper bottle sealing. No reported illnesses or injuries, but sterility compromises in eye medications represent a significant preventable risk to patient health.
Plain-English summary
Apotex Corp. is recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a prescription eye medication. The recall affects 151,034 bottles distributed nationwide, including 5 mL bottles (lot VE0614) and 10 mL bottles (lot VE0616), both with expiration date 12/2025.
The recall was initiated due to improper bottle sealing that has resulted in atypical weight loss of the product. This defect creates a lack of assurance of sterility, which is essential for medications applied directly to the eye.
Patients using the affected lots should discontinue use and contact their pharmacy or healthcare provider for a replacement or alternative medication. The affected lot numbers are VE0614 (5 mL) and VE0616 (10 mL), both expiring 12/2025.
The recalled product
- Product
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION (BRIMONIDINE TARTRATE AND TIMOLOL MALEATE)
- Brand
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Manufacturer
- Apotex Corp.
- Category
- Drug — Ophthalmic
- Hazard
- sterility-assurance
- improper-sealing
Distribution
Distributed nationwide across the United States.
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