Recalls / Class II

Class IID-1822-2019

Product

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.

Affected lot / code info

Lot #: a) 16195, Exp 07/19; 16211, 16216, Exp 08/19; b) 16205, Exp 07/19; 16211, Exp 08/19; c) 16192, 16203, Exp 07/19; 16242, Exp 09/19; 16280, 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, 17012, Exp 01/20; 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20

Why it was 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.

Recalling firm

Firm

Medtech Products, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

660 White Plains Rd Ste 250, N/A, Tarrytown, New York 10591-5171

Distribution

Quantity

6,661,188 bottles

Distribution pattern

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

Timeline

Recall initiated

2019-07-26

FDA classified

2019-08-16

Posted by FDA

2019-08-28

Terminated

2021-03-10

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1822-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.