Apotex recalls Timolol Maleate Ophthalmic Solution 0.5% 2.5mL (Rx only) due to stability issues. Product may lose effectiveness over time, but no immediate safety risk.
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Apotex is recalling Timolol Maleate Ophthalmic Solution 0.5% 2.5mL (Rx only) because it failed stability testing. This means the medication may not work as intended after 18 months, but there is no risk of injury or harm to users.
The medication failed stability testing at the 18-month mark, showing a projected weight loss of 21.1% at shelf life. This means the drug may not be effective after the expiration date, but it does not pose a safety risk to users.
Prescription users of Timolol Maleate Ophthalmic Solution 0.5% 2.5mL (Rx only) manufactured by Apotex Inc. in Toronto, Ontario. People with eye conditions requiring this medication are most at risk.
Check for the product name 'Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL' with the manufacturer Apotex Inc. Toronto, Ontario. The lot number TA4844 and expiration date 03/2023 are also on the label.
Look for the lot number TA4844 and expiration date 03/2023 on the label.
No, the recall is for effectiveness, not safety. The medication may not work as intended after 18 months but does not cause injury.
Check the product label for the lot number TA4844 and expiration date 03/2023. If it matches, contact Apotex for guidance.
No, the recall is due to stability issues affecting effectiveness, not safety.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0093-2023 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0093-2023 from Apotex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
