Apotex recalls Sirolimus Oral Solution (1 mg/mL, 60mL) due to failed dissolution specifications in one lot. This may affect medication effectiveness. Check your product details to see if it's affected.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Apotex is recalling a specific lot of Sirolimus Oral Solution because it failed dissolution tests at 14 months. This could mean the medication isn't working properly for patients who need it.
The medication failed dissolution specifications, meaning it didn't dissolve properly at the 14-month timepoint. This could lead to inconsistent medication levels in the body, potentially affecting treatment effectiveness.
Patients prescribed Sirolimus Oral Solution by a doctor who have the specific lot number RZ1598 are affected. Those with the medication may need to switch to a different product.
Check for the product name 'Sirolimus Oral Solution', 1 mg/mL, 60 mL bottle, and the lot number RZ1598. The expiration date is February 2023.
Look for the lot number RZ1598 on the label to confirm if your medication is affected.
The recall is due to failed dissolution specifications, which could affect medication effectiveness but does not indicate immediate danger to health.
No, but you should check if your medication is the affected lot and contact your doctor if you have concerns.
Check the lot number on the label; if it's RZ1598, it's affected.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-0881-2022 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-0881-2022 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.
