Brimonidine Tartrate/Timolol Maleate Ophthalmic recall: Sterility Concern
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond…
Why was Brimonidine Tartrate/Timolol Maleate Ophthalmic recalled?
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
- Product
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond…
- Recalling firm
- Apotex Corp.
- Quantity
- 151,034 bottles
- Distribution
- Nationwide in the US
- Recall date
- October 8, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)