Key Takeaway

Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 by Medtech Products, Inc. was recalled on July 26, 2019. The hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impac...

FDA Drug Class II Terminated

Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5

Recalled: July 26, 2019 ~66,168 bottles units affected D-1827-2019

Description

Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) 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, case UPC 00678112105434.

Hazard / Reason

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.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5

Drugs

Company Information

Medtech Products, Inc.

Irvington, NY, United States

View all 18 recalls by Medtech Products, Inc. →

Distribution

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

Related Recalls

Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

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