BioGlo Fluorescein Sodium Ophthalmic Strips Recalled Due to Sterility Concerns
Wizcure Pharmaa Private Limited has issued a voluntary recall for over 184,000 containers of BioGlo Fluorescein Sodium Ophthalmic Strips due to a lack of assurance of sterility.
What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of BioGlo Fluorescein Sodium Ophthalmic Strips USP. The recall was triggered due to a lack of assurance of sterility, as the products were found to have been manufactured in a manner that does not conform to current good manufacturing practices (CGMP).
Which Products Are Affected
The recall affects the following product:
- Product Name: BioGlo Fluorescein Sodium Ophthalmic Strips USP (100 diagnostic strips per container)
- NDC Number: 17238-900-11
- Affected Lots: All lots are included in this recall
- Quantity: 184,320 containers
- Distribution: Distributed nationwide across the United States
The product is manufactured by Omni Lens PVT. Ltd. in Ahmedabad, India, and distributed by HUB Pharmaceuticals, LLC, based in Scottsdale, Arizona.
What You Should Do
Healthcare providers and consumers should immediately stop using the affected ophthalmic strips. The recalling firm, Wizcure Pharmaa Private Limited, initiated the notification process via letter. Entities in possession of these products should contact the distributor, HUB Pharmaceuticals, LLC, or the manufacturer for instructions regarding the return or disposal of the affected lots.
Why This Matters
Ophthalmic products that lack assurance of sterility pose a significant health risk. Using non-sterile strips on the eye can lead to serious infections or other ophthalmic complications, particularly during diagnostic procedures.
Source
Information provided by the FDA. Recall Number: D-0352-2026.
Source: FDA Official Notice