Recalls / Class II
Class IID-0407-2026
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.
- 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
- Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
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, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 107,136 vials
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2026-03-05
- FDA classified
- 2026-03-27
- Posted by FDA
- 2026-03-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0407-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.