The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1824-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Drops

Medtech Products is recalling Clear Eyes Maximum Itchy Eye Relief drops due to quality assurance concerns at the manufacturing facility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deviations regarding quality assurance controls. No specific illnesses, injuries, or deaths are reported in the source text, and the hazard is theoretical regarding product quality.

Plain-English summary

Medtech Products, Inc. is recalling 927,108 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops. The product is a 0.5 FL OZ (15 mL) bottle containing Glycerin 0.25%, Naphazoline hydrochloride 0.012%, and Zinc Sulfate 0.25%. The recall involves specific lot numbers with expiration dates ranging from November 2019 to January 2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, there are concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility, which could impact the product quality of the finished products.

The affected product was distributed nationwide in the USA and Puerto Rico, as well as in St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica. Consumers should check their lot numbers and expiration dates against the recall list and stop using the product if it matches the recalled lots.

The recalled product

Product
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, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
927,108

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #: 16302
  • Exp 11/19
  • 16331
  • 16344
  • Exp 12/19
  • 17011
  • 17016
  • Exp 01/20.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Medtech Products, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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