The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1827-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Eye Drops Due to Quality Control Concerns

Medtech Products is recalling Clear Eyes eye drops due to quality assurance concerns at the manufacturing facility. The recall covers 66,168 bottles distributed in the US, Puerto Rico, and several Caribbean nations.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 voluntary precautionary recall.

Plain-English summary

Medtech Products, Inc. is recalling 66,168 bottles of Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display. The recall is due to 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 include Clear Eyes Maximum Redness Relief and Clear Eyes Maximum Itchy Eye Relief eye drops. The recall covers products with Lot # Display 17C30A and an expiration date of 10/19. The 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 return them to the place of purchase for a refund or contact Medtech Products, Inc. for further instructions.

The recalled product

Product
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); and b) Clear eyes MAXIMUM ITCHY…
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
66,168

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 17C30A
  • Exp 10/19

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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