D-0348-2026 Class II Ongoing

Recalled by Wizcure Pharmaa Private Limited — Bhiwadi, N/A

FDA drug recall D-0348-2026 was initiated by Wizcure Pharmaa Private Limited on December 31, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. The recall status is ongoing. Affected quantity: 11,520 cartons.

Recall Details

Product Type
Drugs
Report Date
March 4, 2026
Initiation Date
December 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,520 cartons

Product Description

Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced Dry Eye Relief Revitalizing Formula, 10 ml (1/3 fl.oz.), Wizcure Pharmaa PVT. LTD., H-881, Phase 3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ 85260, NDC 77790-003-10.

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

All lots