Alcon recalls GenTeal Tears and Night-Time Ointment due to improper storage conditions. Products may not meet drug label specifications.
CGMP Deviations: products were stored outside the drug label specifications.
Alcon is recalling GenTe:al Tears, Lubricant Eye Ointment, and Night-Time Ointment because they were stored outside drug label specifications. This could mean the products don't meet required quality standards.
The products were stored outside the drug label specifications, which means they may not meet required quality standards. This could affect the product's safety and effectiveness.
People who own or use GenTeal Tears, Lubricant Eye Ointment, or Night-Time Ointment. Those most at risk are individuals using these products for eye care.
Check for the product name: GenTeal Tears, Lubricant Eye Ointment, or Night-Time Ointment. Look for the NDC code 0065-0518-01 on the packaging.
Look for the NDC code 0065-0518-01 on the packaging to confirm if the product is recalled.
The products were stored outside the drug label specifications, which may affect their quality and safety.
Check the product for the NDC code 0065-0518-01. If you have it, contact Alcon for guidance.
The recall is due to storage issues, not a direct risk of injury. The hazard level is low risk.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall D-1320-2022 — Alcon Alcon Hello, I own a Alcon that is covered by recall D-1320-2022 from Alcon. 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.
