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.
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, 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.
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