The Recall Desk
ModerateFDA (Drugs)·D-1825-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Maximum Redness Relief Eye Drops

Medtech Products is recalling Clear Eyes Maximum Redness Relief eye drops due to quality assurance concerns at 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 situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text cites CGMP deviations and quality assurance concerns without reporting specific illnesses or injuries, aligning with a Moderate severity rating for a precautionary quality control recall.

Plain-English summary

Medtech Products, Inc. is recalling 1,872,984 bottles of Clear Eyes Maximum Redness Relief eye drops. The product is a 0.5 FL OZ (15 mL) bottle containing Glycerin 0.5% and Naphazoline hydrochloride 0.03%. The recall affects specific lots with expiration dates ranging from August 2019 to November 2019.

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 check their bottles for the specific lot numbers and expiration dates listed in the recall notice and stop using the product if it matches the recalled items.

The recalled product

Product
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,872,984

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 (7)

  • Lot #: 16234
  • 16247
  • Exp 08/19
  • 16286
  • Exp 10/19
  • 16314
  • Exp 11/19

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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