The Recall Desk
ModerateFDA (Drugs)·D-1832-2019·Announced 2019-08-28

Medtech Recalls Clear Eyes Maximum Itchy Eye Relief Due to Quality Concerns

Medtech Products is recalling 1,836 bottles of Clear Eyes Maximum Itchy Eye Relief due to concerns about quality assurance controls in 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text cites CGMP deviations and quality assurance concerns without reporting specific illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Medtech Products, Inc. is recalling 1,836 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops. The affected product is sold in 0.5 FL OZ (15 mL) bottles and is part of a floor stand display containing 12 bottles each. The recall covers specific lots (16331, 16344) with an expiration date of 12/19.

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 quality of the finished products.

The affected units 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 inventory for the specific lot numbers and expiration dates listed above. If they possess the recalled product, they should stop using it and contact Medtech Products, Inc. for instructions on return or disposal.

The recalled product

Product
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 7811
Manufacturer
Medtech Products, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
1,836

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 (3)

  • Lot #: 16331
  • 16344
  • Exp 12/19

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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