The Recall Desk
ModerateFDA (Drugs)·D-1828-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Eye Drops Due to Quality Assurance Concerns

Medtech Products, Inc. is recalling Clear Eyes 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, and the source text cites CGMP deviations regarding quality assurance controls without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtech Products, Inc. is recalling 25,992 bottles of Clear Eyes eye drops. The products are sold in assorted sidekick floor stand displays containing three types of eye drops: Redness Relief, Maximum Redness Relief, and Maximum Itchy Eye Relief. The specific lot number for the display is 17E12A, with an expiration date of 09/19.

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 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. Consumers should stop using the recalled products and contact Medtech Products, Inc. for further instructions.

The recalled product

Product
Clear Eyes Assorted Sidekick Floor Stand 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%, Naphazo
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
25,992

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 17E12A
  • Exp 09/19

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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