Red Mountain Compounding Pharmacy recalls all acetylcysteine 2% ophthalmic solution (Rx only) due to FDA sterility concerns. This product may not be sterile, risking infection.
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling all acetylcysteine 2% ophthalmic solution (Rx only) because FDA inspections found sterility issues. Using this product could lead to eye infections.
The FDA found sterility assurance problems during inspections. This means the solution might not be sterile, increasing the risk of eye infections if used.
People with prescriptions for acetylcysteine 2% ophthalmic solution are affected. Those with eye conditions or recent eye surgery are at higher risk.
Check for the product name 'Acetylcysteine 2% Ophthalmic Solution' on the label. It was sold by Red Mountain Compounding Pharmacy and is a prescription-only product.
Look for the product name 'Acetylcyste:ine 2% Ophthalmic Solution' on the label.
The FDA found sterility concerns, so the product may not be sterile and could cause eye infections. Do not use it.
Check the label for 'Acetylcysteine 2% Ophthalmic Solution' and confirm it's a prescription-only product from Red Mountain Compounding Pharmacy.
The recall does not specify a remedy, so contact your healthcare provider for advice on safe alternatives.
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-0054-2022 — Red Mountain Compounding Pharmacy Red Mountain Compounding Pharmacy Hello, I own a Red Mountain Compounding Pharmacy that is covered by recall D-0054-2022 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.
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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.
