FDA Drug recall D-0350-2026
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10
- FDA Drug
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10 by Wizcure Pharmaa Private, citing lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0350-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-31 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Wizcure Pharmaa Private |
| Distribution | US |
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
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Identifiers
| ndc | 83851-100-10 |
|---|---|
| ndc | 83851-100-30 |
| ndc | 83851-100-05 |
| code_info | All lots |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0350-2026%22
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