The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1835-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Redness Relief Eye Drops for Quality Control Issues

Medtech Products, Inc. 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, and the source text cites manufacturing quality control deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medtech Products, Inc. is recalling 314,112 bottles of Clear Eyes Redness Relief Hand Pocket Pal eye drops. The affected products are 0.2 FL OZ (6 mL) bottles containing Glycerin 0.25% and Naphazoline hydrochloride 0.012%. The recall covers specific lots with expiration dates of 02/20, 04/20, and 05/20.

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 quality of the finished products.

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 check their lot numbers and expiration dates against the recalled list and stop using the product if it matches the recalled description.

The recalled product

Product
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) 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); Distributed by…
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
314,112

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 (6)

  • Lot #: 17051
  • Exp 02/20
  • 17130
  • Exp 04/20
  • 17147
  • Exp 05/20

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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