Apotex Corp. Recall: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%,
Apotex Corp. Recall: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Apotex Corp.; Product: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by:
| Recalling firm | Apotex Corp. |
|---|---|
| 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide in the US |
| Recall initiated | 20250905 |
| Recall number | D-0676-2025 |
| Category | drug |
| State | FL |
| Country | United States |
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