The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1829-2019·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 in the manufacturing facility.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, relating to potential quality control deviations rather than a confirmed safety incident, which aligns with the 'Moderate' severity criteria for voluntary precautionary recalls or minor issues without reported harm.

Plain-English summary

Medtech Products, Inc. is recalling Clear Eyes Redness Relief Club Pack Display eye drops. The recall involves 124,038 bottles distributed nationwide in the USA and Puerto Rico, as well as in Barbados, Guyana, Antigua and Barbuda, and Jamaica. The product is a 0.5 FL OZ (15 mL) bottle containing Glycerin 0.25% and Naphazoline hydrochloride 0.12%.

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 FDA has classified this as a Class II recall.

Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact Medtech Products, Inc. for further instructions. The affected lot numbers and expiration dates are listed in the product code information.

The recalled product

Product
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by…
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
124,038

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 (18)

  • Lot #: 3-pack Q16299D2
  • Exp 07/19
  • Q162300D1
  • Q16260B1
  • Q16261B1
  • Q16263B1
  • Q16301D1
  • Q16302D1
  • Q16303D1
  • Q16308D1
  • Q16309D1
  • Q16336D1
  • Q16337D1
  • Q16340D1
  • Q16342D1
  • Q16343D1
  • Q16344D1
  • Exp 08/19

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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