The Recall Desk
ModerateFDA (Drugs)·D-1834-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Concerns

Medtech Products is recalling Clear Eyes Redness Relief eye drops due to quality assurance concerns at the manufacturing facility.

What this means for you

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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites CGMP deviations and quality assurance concerns without reporting specific illnesses or injuries, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Medtech Products, Inc. is recalling 1,030,128 bottles of Clear Eyes Redness Relief (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) size. The product is distributed by Select Corporation and Medtech Products, Inc.

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 lots are 16192 and 16203 (Exp 07/19), 16321 (Exp 11/19), 17002 (Exp 01/20), and 17034 (Exp 02/20). The 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 stop using the product and contact the manufacturer for instructions.

The recalled product

Product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,030,128

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 (9)

  • Lot #: 16192
  • 16203
  • Exp 07/19
  • 16321
  • Exp 11/19
  • 17002
  • Exp 01/20
  • 17034
  • Exp 02/20

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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