PlainRecalls
FDA Drug Moderate Class II Terminated

Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display 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 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.

Reported: August 28, 2019 Initiated: July 26, 2019 #D-1830-2019

Product Description

Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display 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 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.

Reason for Recall

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.

Details

Recalling Firm
Medtech Products, Inc.
Units Affected
1,752 bottles
Distribution
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled? ▼
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display 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 30; Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 10678112106995.. Recalled by Medtech Products, Inc.. Units affected: 1,752 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2019. Severity: Moderate. Recall number: D-1830-2019.

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