Thea Pharma, Inc.: Similasan, Ivizia, Sterile Lubricant Eye Drops (povidone 0.5%), 0.33 Fl Oz (10 Ml), Made In France
Summary Similasan and iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) in 10 mL bottles made in France are being recalled nationwide because the FDA found manufacturing process problems that mean the product's sterility cannot be guaranteed. The recall affects all U.S. states and Washington D.C., and was distributed by Thea Pharma Inc. in Waltham, Massachusetts.
- Recalling firm
- Thea Pharma, Inc.
- Product
- Similasan, 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 59262-700-11
- 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
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-23
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/622f30b2-2550-4fb6-889e-401f572922d2