The Recall Desk
ModerateFDA (Drugs)·D-1831-2019·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 manufacturing quality control concerns.

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 involves CGMP deviations regarding quality assurance controls. No specific illnesses, injuries, or deaths are reported in the source text, and the hazard is theoretical regarding product quality.

Plain-English summary

Medtech Products, Inc. is recalling 17,316 bottles of Clear Eyes Maximum Redness Relief eye drops. The recalled product is sold in Club Pack Displays containing 18 3-Pack bottles. The specific lots involved are Q16322M1, Q16323M1, Q16323M2, and Q16326M1, all with an expiration date of 08/19.

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 product and contact Medtech Products, Inc. for further instructions.

The recalled product

Product
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of 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); Distributed by Medt
Affected units
17,316

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 (5)

  • Lot #: Q16322M1
  • Q16323M1
  • Q16323M2
  • Q16326M1
  • 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 →