Drug product
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
D-0496-2025
Product summary
- Firm
- Apotex Corp.
- Event
- Event 96954
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,288 Bottles
- Official record key
drug-enforcement:D-0496-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch VC6058, Exp Date: 10/31/2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility