The Recall Desk
ModerateFDA (Drugs)·D-1833-2019·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 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 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 a precautionary recall regarding product quality.

Plain-English summary

Medtech Products, Inc. is recalling 793,872 bottles of Clear Eyes Redness Relief Handy Pocket Pal eye drops. The recall involves specific lot numbers with expiration dates ranging from September 2019 to April 2020. The product was 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 who have purchased these specific lots of Clear Eyes Redness Relief eye drops should stop using them and contact Medtech Products, Inc. for further instructions or a refund.

The recalled product

Product
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); Distrib
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
793,872

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 # 16242
  • Exp 09/19
  • 16280
  • Exp 10/19
  • 17051
  • Exp 02/20
  • 17130
  • Exp 04/20

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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