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Class II · ModerateActive recall

Vista Tears Polyethylene Glycol 400 0.4% w/v

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberAll lots
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byRA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260 foreign manufacturer
Distributed by / forhi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260
NDC77790-001-10
Show the full FDA record
Full product labelVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Recalling firmWizcure Pharmaa Private Limited
DistributionDistributed Nationwide in the USA
Quantity5,760 cartons
Recall initiated2025-12-31
Report date2026-03-04
Recall completed
Recall numberD-0346-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBhiwadi N/A India

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.