Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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 Oregon Compounding Centers, Inc. dba Creative Compounds to request your refund or repair — edit it as you like.
Subject: Recall D-0194-2015 — Oregon Compounding Centers, Inc. dba Creative Compounds Oregon Compounding Centers, Inc. dba Creati Hello, I own a Oregon Compounding Centers, Inc. dba Creative Compounds recalls GLUTARALDEHYDE BUFFERED (POTASSIUM PHOSPHATE), solution for irrigation, 250 mL glass bottle, RX, Creative Compounds, that is covered by recall D-0194-2015 from Oregon Compounding Centers, Inc. dba Creative Compounds. 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.
