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Urgent Enforcement Removed Final

Wizcure Pharmaa Drug Recall - Fluorescein Sodium Ophthalmic Strips (Class II)

Favicon for changeflow.com FDA: Drug Recalls Class II
Filed March 4th, 2026
Detected March 28th, 2026
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Summary

The FDA has initiated a Class II drug recall for Wizcure Pharmaa's Fluorescein Sodium Ophthalmic Strips due to a lack of assurance of sterility and non-conformance with current good manufacturing practices. The product was distributed nationwide in the USA.

What changed

Wizcure Pharmaa Private Limited is subject to a Class II drug recall initiated by the FDA for its Fluorescein Sodium Ophthalmic Strips (1mg, 100-count and 300-count boxes, NDC 83851-100-10 and 83851-100-30). The recall is due to a lack of assurance of sterility, stemming from the product not being manufactured in conformance with current Good Manufacturing Practices (cGMP).

This recall signifies a critical failure in manufacturing quality control. Wizcure Pharmaa must immediately cease distribution, notify all relevant parties, and implement a recall plan to retrieve affected products from the market. The FDA's classification as 'Ongoing' suggests active management of the recall process. Failure to comply with recall procedures can result in further enforcement actions and penalties.

What to do next

  1. Cease distribution of affected product
  2. Notify all relevant parties of the recall
  3. Implement product retrieval plan

Source document (simplified)

Wizcure Pharmaa Private Limited

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0350-2026 · 20260304 · Ongoing

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, R...

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

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0350-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls Manufacturing Compliance
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Manufacturing Compliance

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