Thea Pharma recalls iVIZIA sterile lubricant eye drops due to FDA finding CGMP deviations during manufacturing inspection. Products made in France with specific NDC and lot numbers are affected.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Thea Pharma is recalling iVIZIA sterile lubricant eye drops because the FDA found manufacturing quality issues during an inspection. This could mean the product isn't sterile and might cause infections if used.
The FDA found that the manufacturing process did not meet quality standards for sterile products. This could mean the eye drops are not sterile and might cause infections if used.
People who own or use iVIZIA eye drops with the specific NDC 82584-700-11 and lot number 3T36B are affected. Those with the product in their possession are most at risk.
Check for the product name 'iVIZIA', NDC code 82584-700-11, and lot number 3T36B. The product was made in France and expires October 31, 2026.
Look for the NDC code 82584-700-11 and lot number 3T36B on the product label.
The FDA found manufacturing quality deviations during an inspection, which could mean the product isn't sterile.
The official recall notice doesn't specify a remedy, so check with Thea Pharma for guidance.
The recall is due to potential infection risk from non-sterile product, but no specific serious injury mechanism is described.
We’ve drafted a message you can send Thea Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0500-2026 — Thea Pharma Thea Pharma Hello, I own a Thea Pharma that is covered by recall D-0500-2026 from Thea Pharma. 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.
