Recalls / Class II
Class IID-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).
- 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
- 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)
Why it was recalled
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
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
- 151,034 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-09-05
- FDA classified
- 2025-09-30
- Posted by FDA
- 2025-10-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0676-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.