The Recall Desk
SevereFDA (Drugs)·D-0487-2020·Announced 2019-11-27

Clear Eyes Redness Relief Recalled for Lack of Sterility Assurance

Altaire Pharmaceuticals is recalling Clear Eyes Redness Relief eye drops due to a lack of assurance of sterility. Consumers should stop using the product.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or hospitalization reports are rated as Severe (4). While the source does not explicitly state hospitalizations, the lack of sterility assurance in an ophthalmic product poses a significant risk of serious injury, aligning with the Severe criteria for Class II recalls with potential for significant harm.

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling Clear Eyes Redness Relief eye drops, 15 mL bottles, due to a lack of assurance of sterility. The affected products are identified by the following lot numbers and expiration dates: Lot 16195 (Exp 7/19), Lot 16211 (Exp 8/19), and Lot 16216 (Exp 8/19). The product is identified by UPC 6-78112-25415-6.

The recall was initiated because the manufacturer could not ensure the sterility of the product. The source text does not specify the number of units recalled or report any specific illnesses or injuries associated with the use of these products.

Consumers who have purchased these specific lots of Clear Eyes Redness Relief should stop using the product immediately. The source text does not provide specific instructions for disposal or return, but consumers should consult the manufacturer or a healthcare professional for guidance.

The recalled product

Product
Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6
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 (5)

  • Lot #: 16195
  • Exp 7/19
  • 16211
  • Exp 8/19
  • 16216

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 →

Related recalls

Same manufacturer · Altaire Pharmaceuticals, Inc.

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Same hazard · sterility failure

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