Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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 Beacon Hill Medical Pharmacy, P.C. to request your refund or repair — edit it as you like.
Subject: Recall D-938-2013 — Beacon Hill Medical Pharmacy, P.C. Beacon Hill Medical Pharmacy, P.C. recalls ARGININE (R-GENE) 100 Hello, I own a Beacon Hill Medical Pharmacy, P.C. recalls ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded that is covered by recall D-938-2013 from Beacon Hill Medical Pharmacy, P.C.. 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.
