Drug product
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
D-0407-2026
Product summary
- Firm
- Apotex Corp.
- Event
- Event 98536
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 107,136 vials
- Official record key
drug-enforcement:D-0407-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility