Recall Ledger

CHNaO Fluorescein Sodium Ophthalmic Strips recall (Wizcure Pharmaa Private Limited)

DrugClass IIOngoing

Summary: Wizcure Pharmaa Private Limited is recalling 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, Vistam. Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

What is being recalled

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,

Why

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Distributed Nationwide in the USA

How to tell if yours is affected

All lots

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0350-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedDecember 31, 2025
ReportedMarch 4, 2026
CompanyWizcure Pharmaa Private Limited
Company locationBhiwadi, N/A, India
Initiated byVoluntary: Firm initiated
Quantity10,080 boxes

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