FDA recall D-0350-2026

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 for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-12-31

Report date

2026-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bhiwadi, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2026