Home/Recalls/FDA-D-0349-2026
FDA DrugsClass II

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. ...

Published: March 4, 2026Recall ID: D-0349-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.

Additional Source Details

FieldValue
CityBhiwadi
StateN/A
Openfda › UniiB1QE5P712K
Openfda › RouteOPHTHALMIC
Openfda › Spl id312ea999-0542-99ea-e063-6294a90ae29e
Openfda › Brand nameVISTA GONIO EYE LUBRICANT
Openfda › Spl set id00da365d-2988-9c9e-e063-6294a90a8931
Openfda › Package ndc77790-022-15
Openfda › Product ndc77790-022
Openfda › Generic nameHYPROMELLOSE OPHTHALMIC SOLUTION
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameHYPROMELLOSE 2208 (100 MPA.S)
Openfda › Manufacturer nameRed Wedding LLC
Openfda › Application numberM018
Openfda › Is original packagertrue
Event id98253
Address 1H - 881
Address 2N/A
Code infoAll lots
Postal codeN/A
Report date20260304
Product typeDrugs
Product quantity139,104 cartons
Reason for recallLack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20251231
Initial firm notificationLetter
Center classification date20260225

Overview

  • Recalling FirmWizcure Pharmaa Private Limited
  • StatusOngoing
  • Risk LevelClass II
  • DistributionDistributed Nationwide in the USA
Official Agency Alert