Alcon recalls Systane Balance lubricant eye drops 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 Systane Balance lubricant eye drops because they were stored outside the required drug label specifications. This could mean the product does not meet safety standards.
The eye drops were stored outside the drug label specifications, which could affect their safety and effectiveness. This means the product might not meet the required standards for use.
People who own or use Systane Balance lubricant eye drops. Those with sensitive eyes or allergies may be at slightly higher risk.
Check for the product name 'Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ)' on the bottle. The NDC code 0065-1433-02 is also listed.
Look for the product name and NDC code 0065-1433-02 on the bottle.
The product was stored outside the drug label specifications, which could affect its safety and effectiveness.
The recall does not specify a remedy, so check with the manufacturer for further instructions.
The recall states the product was stored outside specifications, but does not mention serious injury risks.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall D-1316-2022 — Alcon Alcon Hello, I own a Alcon that is covered by recall D-1316-2022 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.
