Wizcure Pharmaa Drug Recall - Fluorescein Sodium Ophthalmic Strips (Class II)
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
- Cease distribution of affected product
- Notify all relevant parties of the recall
- 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
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