PlainRecalls
FDA Drug Moderate Class II Terminated

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

Reported: August 17, 2022 Initiated: June 29, 2022 #D-1314-2022

Product Description

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

Reason for Recall

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

Details

Units Affected
47 bottles
Distribution
Nationwide in the USA.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 47 bottles.
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-1314-2022.