Class II
Ongoing
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).
- Company
- Apotex Corp.
- Recall Initiated
- September 5, 2025
- Posted
- October 8, 2025
- Recall Number
- D-0676-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 151,034 bottles
- Firm Location
- Weston, FL, United States
Reason for Recall
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Distribution
Nationwide in the US
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)
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