Drug recall D-0500-2026
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
Reason for recall
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lots and codes
Lot#: 3T36B, Exp. Date October 31, 2026.
Recall details
- Recalling firm
- Thea Pharma, Inc., Waltham, MA
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 23, 2026
Related products
- iVIZIA Dry Eye – drug information
- NDC 82584-700 iVIZIA Dry Eye · Povidone 25 mg/5mL · Thea Pharma Inc.