FDA-Drug2026-03-04Class IIPROCESSING DEFECT
Wizcure Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
What this means
Wizcure Fluorescein Sodium Ophthalmic Strips (1mg) were not manufactured following proper sterilization standards. These strips are used by eye care professionals to examine the eye surface. Because sterility cannot be assured, there is a potential risk of contamination.
- Stop using the product immediately if you have it
- Contact your eye doctor or pharmacy if you recently used these strips
- Do not use any boxes with NDC 83851-100-10 or 83851-100-30
- Check with your eye care provider about safe alternatives
The agency's original wording
Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
10,080 boxes
Manufactured in
H - 881, N/A, Bhiwadi, N/A, India
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2026Want us to check the next one for you?
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