FDAClass IINovember 27, 2019

FreshKote Lubricant Eye Drops recall: Sterility Concern

FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15

Why was FreshKote Lubricant Eye Drops recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 18095, Exp 4/20

Product
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
31070 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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