The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0483-2020·Announced 2019-11-27

Altaire Recalls FreshKote Lubricant Eye Drops Due to Sterility Concerns

Altaire Pharmaceuticals is recalling FreshKote Lubricant 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 rubric specifies that FDA Class II recalls involving significant risks or hospitalization reports are rated as Severe (4).

Plain-English summary

Altaire Pharmaceuticals, Inc. is recalling FreshKote Lubricant Eye Drops, 15 mL (NDC 15821-101-15), due to a lack of assurance of sterility. The recall affects 31,070 units distributed nationwide in the United States. The specific lot number is 18095, with an expiration date of 4/20.

The recall was initiated because the manufacturer cannot guarantee that the eye drops are sterile. This classification is designated as Class II by the U.S. Food and Drug Administration.

Consumers who have this product should stop using it and contact Altaire Pharmaceuticals for instructions on how to return or dispose of the medication.

The recalled product

Product
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
31,070

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 (2)

  • Lot #: 18095
  • Exp 4/20

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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