FDA DrugsClass II
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 m...
Published: May 6, 2026Recall ID: D-0501-2026Category: drugsCountry: US
Reason for Recall / 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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Event id | 98792 |
| Address 1 | 303 Wyman St |
| Code info | Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026. |
| Postal code | 02451-1208 |
| Report date | 20260506 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260423 |
| Initial firm notification | Letter |
| Center classification date | 20260428 |
Overview
- Recalling FirmThea Pharma, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States