FDA-Drug2019-08-28Class II
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
Medtech Products, Inc.
Hazard
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Sold states
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Affected count
1,836 bottles
Manufactured in
660 White Plains Rd Ste 250, N/A, Tarrytown, NY, United States
Products
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3), Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1832-2019Don't want to check this manually?
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