AbbVie Inc.: Drug Recall

Recall #D-0664-2024 · 09/16/2024

Class II: Risk

Recall Details

Recall Number: D-0664-2024
Classification: Class II
Product Type: Drug
Recalling Firm: AbbVie Inc.
Status: Ongoing
Date Initiated: 09/16/2024
Location: North Chicago, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,473,563 tubes

Reason for Recall

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Product Description

Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,

Distribution Pattern

Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)

Other Recalls by AbbVie Inc.

Class II: Risk 09/16/2024

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class III: Low Risk 10/17/2023

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

View all recalls by AbbVie Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.