FDAFDA · Food and drugs·Recall number D-0676-2025
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).
Published October 8, 2025 · Recall initiated: September 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
- Manufacturer
- Apotex Corp.
- Distributor
- Nationwide in the US
- Lot
- 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)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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