Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufac...
Reason for Recall / Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product Description & Identification
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Affected Products
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Additional Source Details
| Field | Value |
|---|---|
| City | Bhiwadi |
| State | N/A |
| Event id | 98253 |
| Address 1 | H - 881 |
| Address 2 | N/A |
| Code info | All lots |
| Postal code | N/A |
| Report date | 20260304 |
| Product type | Drugs |
| Product quantity | 50,400 Boxes |
| Reason for recall | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251231 |
| Initial firm notification | Letter |
| Center classification date | 20260225 |
Overview
- Recalling FirmWizcure Pharmaa Private Limited
- StatusOngoing
- Risk LevelClass II
- DistributionDistributed Nationwide in the USA