Wizcure Pharmaa Recalls Bio Glo Fluorescein Sodium Ophthalmic Strips Due to Sterility Concerns
Wizcure Pharmaa Private Limited is recalling 50,400 boxes of Bio Glo Fluorescein Sodium Ophthalmic Strips USP nationwide due to manufacturing concerns and lack of sterility assurance.
What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of Bio Glo Fluorescein Sodium Ophthalmic Strips USP. The recall was issued due to a lack of assurance of sterility, as the products were not manufactured in conformance with current good manufacturing practices (CGMP).
Which Products Are Affected
The recall includes all lots of the following product:
- Product Name: Bio Glo Fluorescein Sodium Ophthalmic Strips USP
- Packaging: 300 diagnostic strips per box
- NDC Number: 17238-900-30
- Quantity: 50,400 boxes
- Manufacturer: Omni Lens Pvt Ltd (Ahmedabad, India)
- Distributor: HUB Pharmaceuticals, LLC (Scottsdale, AZ)
These products were distributed nationwide throughout the United States.
What You Should Do
Healthcare professionals and consumers are advised to stop using the affected ophthalmic strips immediately. The firm initiated the recall via letter notification. For further information regarding the return of the product or to address safety concerns, consumers should contact the distributor, HUB Pharmaceuticals, LLC, or the recalling firm, Wizcure Pharmaa Private Limited.
Why This Matters
Sterility is a critical safety requirement for ophthalmic products. Using diagnostic strips that do not meet sterility standards can lead to serious eye infections or other health complications for patients.
Source
Information provided by the FDA under recall number D-0351-2026.
Source: FDA Official Notice