FDA-Drug2019-08-28Class II
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); 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
6,661,188 bottles
Manufactured in
660 White Plains Rd Ste 250, N/A, Tarrytown, NY, United States
Products
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); 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-1822-2019Don't want to check this manually?
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