CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
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 Sanofi-Aventis U.S. LLC to request your refund or repair — edit it as you like.
Subject: Recall D-0534-2020 — Sanofi-Aventis U.S. LLC Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 1 Hello, I own a Sanofi-Aventis U.S. LLC recalls Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, that is covered by recall D-0534-2020 from Sanofi-Aventis U.S. LLC. 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.
