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Class II · ModerateActive recall

C20H10Na2O5 Fluorescein Sodium Ophthalmic Strips

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 byWizcure 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 foreign manufacturer
Brand nameC20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Generic nameFLUORESCEIN SODIUM
Active ingredient(s)FLUORESCEIN SODIUM
Distributed by / forWizcure Pharmaa Private Limited
NDC83851-100-10
Show the full FDA record
Full product labelCHNaO 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,
Recalling firmWizcure Pharmaa Private Limited
DistributionDistributed Nationwide in the USA
Quantity10,080 boxes
Recall initiated2025-12-31
Report date2026-03-04
Recall completed—
Recall numberD-0350-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBhiwadi N/A India

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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.