Recalls / Class II
Class IID-0496-2025
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
- Brand name
- Brimonidine Tartrate/timolol Maleate Ophthalmic Solution
- Generic name
- Brimonidine Tartrate And Timolol Maleate
- Active ingredients
- Brimonidine Tartrate, Timolol Maleate
- Route
- Ophthalmic
- NDC
- 60505-0589
- FDA application
- ANDA091442
- Affected lot / code info
- Batch VC6058, Exp Date: 10/31/2025
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 6,288 Bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-05-28
- FDA classified
- 2025-06-25
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0496-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.