Drug FDA Class II Ongoing Contamination / non-sterility

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

Wizcure Pharmaa Private Limited Published Mar 4, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Wizcure Pharmaa Private Limited or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Hazards

Lack of Assurance of Sterility · primary

Affected products (1)

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,

C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS · 10,080 boxes

NDC: 83851-100, 83851-100-10, 83851-100-30, 83851-100-05

Code info: All lots

Affected areas

Nationwide

Timeline

Initiated

Dec 31, 2025
Published

Mar 4, 2026

Recall number: D-0350-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.