Recall: D-0676-2025
Class II - Potentially Harmful
Class IIClassification
2025-09-05Initiated
OngoingStatus
Apotex Corp.Firm
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
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Distribution
Nationwide in the US
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.