Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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 Fresenius Kabi USA LLC (FK USA) to request your refund or repair — edit it as you like.
Subject: Recall D-915-2013 — Fresenius Kabi USA LLC (FK USA) Fresenius Kabi USA LLC (FK USA) recalls IRINOTECAN HYDROCHLORIDE INJ Hello, I own a Fresenius Kabi USA LLC (FK USA) recalls IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP that is covered by recall D-915-2013 from Fresenius Kabi USA LLC (FK USA). 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.