Failed Dissolution Specifications: Out of specification result for dissolution.
Failed Dissolution Specifications: Out of specification result for dissolution.
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 Chiesi USA, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-1341-2019 — Chiesi USA, Inc. Chiesi USA, Inc. recalls ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120 Hello, I own a Chiesi USA, Inc. recalls ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., that is covered by recall D-1341-2019 from Chiesi USA, Inc.. 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.
