Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Thea LaboratoiresLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Thea Pharma with 9 drug applications, 3 drug recalls and 1 warning letter. The most recent is a drug recall dated Apr 23, 2026: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 23, 2026 | Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., WalthaClass II · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspect | Drug recalls |
| Apr 23, 2026 | iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451Class II · Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspect | Drug recalls |
| Jul 9, 2025 | Warning letter: Unapproved new drugCDER | Warning letters |
| Mar 5, 2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15Class II · Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
