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Thea Pharma, Inc.: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltha

DrugsSource: FDA (drug) · Date: 2026-05-06

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
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
Status
Ongoing
Distribution / sold at
Nationwide within the United States
Recall initiated
2026-04-23
Code info
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Voluntary mandated
Voluntary: Firm initiated
City
Waltham
State
MA
Country
United States
Event id
98792
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