Red Mountain Compounding Pharmacy recalls cyclosporin eye drops (0.2% oil suspension) 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 has recalled all cyclosporin eye drops (0.2% oil suspension) because an FDA inspection found sterility assurance issues. This could lead to infections if the medication is not sterile.
The FDA inspection identified concerns about the medication's sterility assurance. If the eye drops are not sterile, they could cause serious infections, especially in individuals with weakened immune systems.
People who have been prescribed cyclosporin eye drops by a doctor and received them from Red Mountain Compounding Pharmacy. Those with compromised immune systems are at higher risk for infections.
Check the product label for 'CYCLOSPORIN 0.2% OIL OPTH SUSP' and the manufacturer name 'Red Mountain Compounding Pharmacy'. All lots within the expiry date are affected.
Look for the product name 'CYCLOSPORIN 0.2% OIL OPTH SUSP' and the manufacturer 'Red Mountain Compounding Pharmacy'.
The FDA has raised sterility concerns, so the product is not safe to use without recalling it.
The official recall notice does not mention refunds or returns.
The recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
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-0034-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0034-2022 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.
