Lack of Assurance of Sterility; container closure issues with the bulk batch.
Lack of Assurance of Sterility; container closure issues with the bulk batch.
We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
We’ve drafted a message you can send F. Hoffmann-LaRoche Ltd. to request your refund or repair — edit it as you like.
Subject: Recall D-105-2013 — F. Hoffmann-LaRoche Ltd. F. Hoffmann-LaRoche Ltd. recalls Cymevene 500 mg Powder for Infusion, (ganc Hello, I own a F. Hoffmann-LaRoche Ltd. recalls Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche that is covered by recall D-105-2013 from F. Hoffmann-LaRoche Ltd.. 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.
