Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
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 Axcentria Pharmaceuticals, LLC to request your refund or repair — edit it as you like.
Subject: Recall D-1434-2014 — Axcentria Pharmaceuticals, LLC Axcentria Pharmaceuticals, LLC recalls Hemo-Stat Solution, Aluminum Hello, I own a Axcentria Pharmaceuticals, LLC recalls Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also that is covered by recall D-1434-2014 from Axcentria Pharmaceuticals, 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.
