Home / Recalls / Medtech Products, Inc. / D-1833-2019

D-1833-2019 Class II Terminated

Recalled by Medtech Products, Inc. — Tarrytown, NY

Recall Details

Product Type
Drugs
Report Date
August 28, 2019
Initiation Date
July 26, 2019
Termination Date
March 10, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
793,872 bottles

Product Description

Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 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.

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.

Distribution Pattern

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

Code Information

Lot # 16242, Exp 09/19; 16280, Exp 10/19; 17051, Exp 02/20; 17130, Exp 04/20

Other recalls by Medtech Products, Inc.

  • D-1828-2019 Class II — Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each o (July 26, 2019)
  • D-1835-2019 Class II — Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 7811 (July 26, 2019)
  • D-1832-2019 Class II — Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display ( (July 26, 2019)
  • D-1826-2019 Class II — Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes R (July 26, 2019)
  • D-1822-2019 Class II — Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye (July 26, 2019)
  • D-1834-2019 Class II — Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye (July 26, 2019)
  • D-1829-2019 Class II — Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bot (July 26, 2019)
  • D-1831-2019 Class II — Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3- (July 26, 2019)
  • D-1830-2019 Class II — Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display c (July 26, 2019)
  • D-1825-2019 Class II — Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03 (July 26, 2019)