The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0490-2020·Announced 2019-11-27

Clear Eyes Redness Relief Recalled Due to Sterility Assurance Issues

Altaire Pharmaceuticals is recalling Clear Eyes Redness Relief eye drops because the company cannot ensure the product is sterile.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance for an ophthalmic product, which poses a significant risk of serious injury or infection.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Clear Eyes Redness Relief (Little Drug), 0.2 FL. Oz. eye drops. The recall was initiated due to a lack of assurance of sterility for the affected product.

The affected lots include 16321 (Exp 11/19), 16336 (Exp 12/19), 17012 (Exp 1/20), 17034 (Exp 2/20), 17051 (Exp 2/20), and 17147 (Exp 5/20). The product was distributed nationwide in the United States.

Consumers should check their eye drop bottles for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard

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 (11)

  • Lot #: 16321
  • Exp 11/19
  • 16336
  • Exp 12/19
  • 17012
  • Exp 1/20
  • 17034
  • Exp 2/20
  • 17051
  • 17147
  • Exp 5/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 134 recalled by Altaire Pharmaceuticals, 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 134 products in this recall →

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