CHNaO Fluorescein Sodium Ophthalmic Strips — Class II drug recall D-0350-2026
Ongoing recall by Wizcure Pharmaa Private Limited, reported 2026-03-04, distributed nationwide. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufactu
| Recall number | D-0350-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wizcure Pharmaa Private Limited, Bhiwadi, N/A, India |
| Recall initiated | 2025-12-31 |
| Classified | 2026-02-25 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 10,080 boxes |
| Reason classes | sterility, cgmp |
| NDC | 83851-0100, 83851-0100-05, 83851-0100-10, 83851-0100-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0350-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.