PlainRecalls
FDA Drug Moderate Class II Terminated

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

Reported: August 17, 2022 Initiated: June 29, 2022 #D-1320-2022

Product Description

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

Reason for Recall

CGMP Deviations: products were stored outside the drug label specifications.

Details

Units Affected
40 boxes
Distribution
Nationwide in the USA.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 40 boxes.
Why was this product recalled?
CGMP Deviations: products were stored outside the drug label specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 17, 2022. Severity: Moderate. Recall number: D-1320-2022.