Systane Lubricant Solution/ Drops
FDA Recall NDC 0065-0429
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Systane Lubricant (NDC 0065-0429). A significant event, classified as Class II, was initiated on Jun 29, 2022 by Alcon Laboratories, Inc.. The reported reason for this action was: "CGMP Deviations: products were stored outside the drug label specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Jun 29, 2022
Aug 17, 2022
47 bottles
Recall Profile & Regulatory Data
Event ID
90553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 13, 2024
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.
Batch or Lot Expiration Information
Lot# Part# a) 0065042915, b) 0065042930
Affected Packages Involved in this Recall
0065-0429-15Product
0065-0429-21Product
0065-0429-30Product
0065-0429-36Product
0065-0429-67Product
0065042915Product
0065042930Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
