PlainRecalls
FDA Drug Moderate Class II Ongoing

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,

Reported: October 2, 2024 Initiated: September 16, 2024 #D-0664-2024

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,

Reason for Recall

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

Details

Recalling Firm
AbbVie Inc.
Units Affected
2,473,563 tubes
Distribution
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Location
North Chicago, IL

Frequently Asked Questions

What product was recalled?
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,. Recalled by AbbVie Inc.. Units affected: 2,473,563 tubes.
Why was this product recalled?
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 2, 2024. Severity: Moderate. Recall number: D-0664-2024.