iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Quick Facts at a Glance
- Recall Date
- April 23, 2026
- Hazard Level
- HIGH
- Brands
- IVIZIA DRY EYE, Thea Pharma Inc.
- Geographic Scope
- 1 states
Hazard Information
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Thea Pharma, Inc. or your healthcare provider for guidance. Notification method: Letter
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Full Description
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11. Generic: POVIDONE; Brand: IVIZIA DRY EYE. Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.. Classification: Class II. Distribution: Nationwide within the United States
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