Thea Pharma, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0501-2026Class IISimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, April 23, 2026
D-0500-2026Class IIiVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, DistributedApril 23, 2026
D-0374-2024Class IIBetimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma InMarch 5, 2024