Red Mountain Compounding Pharmacy recalls ACETYLCYSTEINE 10% OPTH SOLN due to FDA sterility concerns. All lots within expiry date are affected.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling all ACETYLCYSTEINE 10% OPTH SOLN products due to sterility concerns identified during FDA inspections. This could pose a risk of infection if the medication is used without proper sterility.
FDA inspections found issues with sterility assurance for this medication. If the product is not sterile, it could cause infections when used in the eye, especially for people with sensitive eye conditions.
People who have purchased or received ACETYLCYSTEINE 10% OPTH SOLN from Red Mountain Compounding Pharmacy. Those with eye conditions requiring this medication are at higher risk.
Check for the product name 'ACETYLCYSTEINE 10% OPTH SOLN' and the manufacturer 'Red Mountain Compounding Pharmacy'. All lots within the expiry date are affected.
Identify if you have ACETYLCYSTEINE 10% OPTH SOLN from Red Mountain Compounding Pharmacy.
The FDA identified sterility concerns, so the product may not be safe for use in the eye. Do not use until the recall is resolved.
The recall record does not specify a replacement process or remedy.
The recall record does not provide specific instructions for disposal or return.
We’ve drafted a message you can send Red Mountain Compounding Pharmacy to request your refund or repair — edit it as you like.
Subject: Recall D-0053-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0053-2022 from Red Mountain Compounding Pharmacy. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
