Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea
Summary
The FDA issued a Class II for Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 m by Thea Pharma, Inc.. 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..
Details
Source
Drug Recall
External ID
D-0501-2026
Action Date
2026-05-06
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
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.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-23
Company
Waltham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Thea Pharma, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Thea Pharma, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Thea Pharma, Inc. have FDA actions?
Thea Pharma, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0501-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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