PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: November 27, 2019 Initiated: July 2, 2019 #D-0483-2020

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Details

Units Affected
31070 units
Distribution
U.S.A. Nationwide
Location
Aquebogue, NY

Frequently Asked Questions

What product was recalled?
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15. Recalled by Altaire Pharmaceuticals, Inc.. Units affected: 31070 units.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on November 27, 2019. Severity: Moderate. Recall number: D-0483-2020.