Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution Recall
Apotex Corp. is recalling 6,288 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution nationwide due to lack of assurance of sterility. The affected batch (VC6058, expiration date 10/31/2025) does not meet sterility requirements for ophthalmic use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility defect in an ophthalmic drug product. Lack of sterility assurance in injectable/ophthalmic formulations represents a serious risk of infection and meets the Class II severity threshold for drug recalls.
Plain-English summary
Apotex Corp. is recalling Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% (15 mL bottles) due to lack of assurance of sterility. The recall affects batch VC6058 with expiration date 10/31/2025, representing 6,288 bottles distributed nationwide.
This eye drop medication is a prescription drug used to treat elevated intraocular pressure. The product is manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, Florida.
Patients currently using this medication should contact their healthcare provider or pharmacist immediately. Do not use the product if the batch number and expiration date match VC6058 and 10/31/2025. Consumers with questions may contact the FDA or the manufacturer.
The FDA classified this as a Class II recall. Patients should seek medical guidance before discontinuing use of their glaucoma medication.
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 / Eye Drop
- Hazard
- sterility-assurance
- microbial-contamination
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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