Fluorescein Sodium Ophthalmic Strips Recall: BioGlo USP 1 mg
Announced 2026-03-04 · FDA
The FDA is recalling all lots of Fluorescein Sodium Ophthalmic Strips, USP 1 mg, packaged as 100-count and 300-count boxes. The recall is due to lack of assurance of sterility and products not manufactured in conformance with current good manufacturing practices. Affected distribution was nationwide in the United States; no corrective action is provided in the available information.
| Brand | Wizcure Pharmaa Private Limited |
|---|---|
| Product | CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India, |
| Reason | Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. |
| Severity | moderate |
| Units affected | 184320 |
| Distribution | Distributed Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | All lots |
WHAT YOU SHOULD DO
- Stop using any affected Fluorescein Sodium Ophthalmic Strips and set them aside.
- Contact Wizcure Pharmaa Private Limited for return or disposal instructions and to arrange replacement if applicable.
- If you have used the product and have eye irritation or other problems, consult your eye care professional.
- Report any adverse events to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.