The Recall Desk
ModerateFDA (Drugs)·D-1826-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Assorted Displays Due to Quality Control Concerns

Medtech Products is recalling Clear Eyes Assorted IRC Displays 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 temporary or medically reversible adverse health consequence. 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 Clear Eyes Assorted IRC Displays. Each display contains 20,808 bottles of three types of eye drops: Redness Relief, Maximum Redness Relief, and Maximum Itchy Eye Relief. The products were 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 check their displays for the specific lot number 17E23A and expiration date 12/19. If you have this product, you should stop using it and contact Medtech Products for further instructions.

The recalled product

Product
Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochlorid
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
20,808

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 (2)

  • Lot #: Display 17E23A
  • Exp 12/19

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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