Genentech recalls Xolair 150mg prefilled syringes due to stability problems detected at 12 months. Affected lots expired August 2021. No remedy specified in official notice.
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Genentech is recalling Xolair 150mg prefilled syringes that failed stability tests after 12 months. This means the medication may not be safe for use once the expiration date passes. Affected products were manufactured in August 2021 and should be checked for the specific lot numbers.
The medication failed stability tests at the 12-month mark, indicating potential degradation of the active ingredient. This could lead to ineffective treatment or adverse reactions if used beyond the expiration date.
People with prescriptions for Xolair 150mg injections who received the recalled lots (3352758 or 3352759) from August 2021. Those using the product after the expiration date may be at risk.
Check the product label for the lot number 3352758 or 3352759 with expiration date August 2021. The product is a single-dose prefilled syringe for subcutaneous use.
Look for lot numbers 3352758 or 3352759 with expiration date August 2021 on the syringe.
The official recall notice does not specify any remedy for this product.
Check the product label for lot numbers 3352758 or 3352759 with expiration date August 2021. If you have these, contact your healthcare provider for guidance.
The recall indicates stability issues detected at 12 months, but the official notice does not specify a safe usage period beyond the expiration date.
We’ve drafted a message you can send Genentech to request your refund or repair — edit it as you like.
Subject: Recall D-0650-2021 — Genentech Genentech Hello, I own a Genentech that is covered by recall D-0650-2021 from Genentech. 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.
