FDA-Drug2019-08-28Class II
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.
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
1,621,200 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, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1823-2019Don't want to check this manually?
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