The Recall Desk
ModerateFDA (Drugs)·D-1822-2019·Announced 2019-08-28

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

Medtech Products, Inc. is recalling Clear Eyes Redness Relief eye drops due to concerns about quality assurance controls 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 involves a reasonable probability of 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 criteria for a moderate severity score.

Plain-English summary

Medtech Products, Inc. is recalling approximately 6.7 million bottles of Clear Eyes Redness Relief eye drops. The recall involves 0.5 FL OZ, 1 FL OZ, and 0.2 FL OZ (Handy Pocket Pal) bottles distributed nationwide in the USA and Puerto Rico, as well as in Barbados, Guyana, Antigua and Barbuda, and Jamaica.

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.

Consumers should stop using the recalled eye drops and return them to the place of purchase for a refund. The affected lots include specific expiration dates ranging from July 2019 to May 2020, as detailed in the recall notice.

The recalled product

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
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
6,661,188

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 (20)

  • Lot #: a) 16195
  • Exp 07/19
  • 16211
  • 16216
  • Exp 08/19
  • b) 16205
  • c) 16192
  • 16203
  • 16242
  • Exp 09/19
  • 16280
  • 16285
  • Exp 10/19
  • 16300
  • Exp 11/19
  • 16336
  • Exp 12/19
  • 17002
  • 17012
  • 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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