iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, D… recall

Why it was recalled

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

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

Recalling company

Thea Pharma

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide within the United States

Initiated

Apr 23, 2026

FDA report date

May 6, 2026