Drug recall D-0676-2025
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 Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Reason for recall
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Lots and codes
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)
Recall details
- Recalling firm
- Apotex Corp., Weston, FL
- Quantity
- 151,034 bottles
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 5, 2025
Related products
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution – drug information
- NDC 60505-0589 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution · Brimonidine Tartrate 2 mg/mL; Timolol Maleate 5 mg/mL · Apotex Corp.