Data Composite

Recall D-0676-2025

US Class II Ongoing · initiated 2025-09-05

Recalling firm

Apotex Corp., FL

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).

Reason for recall

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns

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