Apotex Inc. recalled 151,034 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution on September 5, 2025. The recall stems from a lack of assurance of sterility due to improper bottle sealing. Consumers should stop using the product immediately and contact their healthcare provider or Apotex Corp.
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Consumers and healthcare providers should stop using this product immediately. Contact Apotex Corp. or your healthcare provider for guidance. Notification method: Letter
The recalled products include 5 mL and 10 mL bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution. The NDC for the 5 mL bottle is 60505-0589-1 and for the 10 mL bottle, it is 60505-0589-2. These products were distributed nationwide in the United States.
The recall was initiated due to a lack of assurance of sterility resulting from atypical weight loss caused by improper bottle sealing. This defect raises concerns about the product's safety and efficacy.
As of now, there have been no reported incidents or injuries associated with the use of the recalled ophthalmic solution. However, the potential risk to consumers remains high.
Consumers and healthcare providers should stop using the product immediately. Contact Apotex Corp. or your healthcare provider for further guidance.
For more information, consumers can visit the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0676-2025 or call Apotex Corp.
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