C20h10na2o5 Fluorescein Sodium Ophthalmic Strips Strip
FDA Recall NDC 83851-100
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with C20h10na2o5 Fluorescein Sodium Ophthalmic Strips (NDC 83851-100). A significant event, classified as Class II, was initiated on Dec 31, 2025 by Vistamerica Usa. The reported reason for this action was: "Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Dec 31, 2025
Mar 04, 2026
10,080 boxes
Recall Profile & Regulatory Data
Event ID
98253
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Wizcure Pharmaa Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Product Description
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,
Batch or Lot Expiration Information
Lot# All lots
Affected Packages Involved in this Recall
83851-100-10Product
83851-100-30Product
83851-100-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
