Medtech Products, Inc. recalls Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 m

Recalled August 28, 2019 · FDA recall D-1823-2019 · Medtech Products

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. · FDA Class II

Units

1,621,200 bottles

Sold at

Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

Description

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.

Product

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.

Manufacturer(s)

Medtech Products, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →