← FDA ENFORCEMENT
D-0350-2026Class II

Wizcure Pharmaa Private Limited

Recalling firm
Wizcure Pharmaa Private Limited
Product type
Drug
Status
Ongoing
Report date
2026-03-04
Distribution
Distributed Nationwide in the USA
Firm state
N/A
Product quantity
10,080 boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

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,

Code / lot info

All lots

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.