Refresh Relieva Preservative Free Solution/ Drops
FDA Recall NDC 0023-6634
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 Refresh Relieva Preservative Free (NDC 0023-6634). A significant event, classified as Class II, was initiated on Dec 30, 2020 by Allergan, Inc.. The reported reason for this action was: "Labeling: Missing instructions for use insert"
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
Labeling: Missing instructions for use insert
Dec 30, 2020
Jan 27, 2021
100,634 bottles
Recall Profile & Regulatory Data
Event ID
87016
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Allergan, PLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jun 21, 2023
Product Description
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) Sterile Distributed by: Allergan, an AbbVie company Madison, NJ 07940 UPC 3 00236 63410 0, NDC 0023-6634-10.
Batch or Lot Expiration Information
Lot# Lots: T0392 Exp. Jul. 2022, T0843 Exp. Aug. 2022
Affected Packages Involved in this Recall
0023-6634-10Product
0023-6634-01Product
0023-6634-20Product
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.
