FDA DrugsClass II
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in...
Published: May 6, 2026Recall ID: D-0500-2026Category: 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
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
Additional Source Details
| Field | Value |
|---|---|
| City | Waltham |
| State | MA |
| Openfda › Unii | FZ989GH94E |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 2570860 |
| Openfda › Rxcui › 2 | 2586186 |
| Openfda › Spl id | 4197af7c-fb98-684b-e063-6394a90a64cf |
| Openfda › Brand name | IVIZIA DRY EYE |
| Openfda › Spl set id | 1ef73cb1-da48-a713-e063-6294a90afa9d |
| Openfda › Package ndc › 1 | 82584-700-05 |
| Openfda › Package ndc › 2 | 82584-700-11 |
| Openfda › Package ndc › 3 | 82584-700-13 |
| Openfda › Product ndc | 82584-700 |
| Openfda › Generic name | POVIDONE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | POVIDONE |
| Openfda › Manufacturer name | Thea Pharma Inc. |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 98792 |
| Address 1 | 303 Wyman St |
| Code info | Lot#: 3T36B, Exp. Date October 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