Thea Pharma, Inc.: 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
Read the official notice at FDA (drug) →
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
- 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 / 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#: 3T36B, Exp. Date October 31, 2026.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waltham
- State
- MA
- Country
- United States
- Event id
- 98792
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