Prescription Eye Drops Recalled for Sterility Assurance Issues
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate eye drops nationwide due to lack of sterility assurance. Patients should verify their batch number and contact their healthcare provider.
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 solution with no reported illnesses or injuries. The hazard is theoretical (sterility assurance failure, not confirmed contamination). Ophthalmic products are high-risk because eye drops contact sensitive eye tissue directly. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Apotex Corp. is recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution (0.2%/0.5%), a prescription eye medication. The recall covers 6,288 bottles from batch VC6058 (expiration date October 31, 2025) distributed nationwide.
The recall is due to lack of assurance of sterility in the affected batch. Non-sterile eye medications could pose health risks.
Patients using the recalled batch should check the batch number on their medication and contact their healthcare provider. Do not stop using the medication without medical guidance. Your doctor or pharmacist can confirm whether your supply is affected and discuss alternatives if necessary.
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-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch VC6058
- Exp Date: 10/31/2025
Distribution
Distributed nationwide across the United States.
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