FDARecalled May 6, 2026 · #D-0500-2026
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
Hazard
Class II — temporary health risk
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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
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Thea Pharma, Inc.
- Model numbers
- 3T36B
- UPCs
- —