Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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 THE COMPOUNDING SHOP, INC. to request your refund or repair — edit it as you like.
Subject: Recall D-560-2013 — THE COMPOUNDING SHOP, INC. THE COMPOUNDING SHOP, INC. recalls Mitomycin 0.3 mg/mL Injectable, 10 mL Hello, I own a THE COMPOUNDING SHOP, INC. recalls Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL that is covered by recall D-560-2013 from THE COMPOUNDING SHOP, 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.
