The Recall Desk
ModerateFDA (Drugs)·D-1823-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

Medtech Products is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls in 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 involves 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 regarding quality assurance controls without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtech Products, Inc. is recalling approximately 1,621,200 bottles of Clear Eyes Redness Relief eye drops. The product is a 0.2 FL OZ (6 mL) Handy Pocket Pal bottle containing Glycerin 0.25% and Naphazoline hydrochloride 0.012%. The recall is being conducted due to concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility, which could impact the quality of the finished products.

The affected products were 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. The specific lot numbers and expiration dates involved are: 16321 (Exp 11/19), 16336 (Exp 12/19), 17012 (Exp 01/20), 17034 and 17051 (Exp 02/20), and 17147 (Exp 05/20). The product is distributed by Lil' Drug Store Products Inc. and Medtech Products Inc.

Consumers should check their inventory for these specific lot numbers and expiration dates. If they possess the recalled product, they should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.

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, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,621,200

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 (11)

  • Lot #: 16321
  • Exp 11/19
  • 16336
  • Exp 12/19
  • 17012
  • Exp 01/20
  • 17034
  • 17051
  • Exp 02/20
  • 17147
  • Exp 05/20

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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