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Wizcure Pharmaa Private Limited: 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. Ma

DrugsSource: FDA (drug) · Date: 2026-03-04

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / 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 / hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distributed Nationwide in the USA
Recall initiated
2025-12-31
Code info
All lots
Product quantity
10,080 boxes
Voluntary mandated
Voluntary: Firm initiated
City
Bhiwadi
State
N/A
Country
India
Event id
98253
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