Refresh P recalled over undeclared allergens

Recall date

September 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AbbVie Inc. recalls Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distribu…

Recall number

D-0664-2024

FDA classification

Class II

Brand / firm

AbbVie Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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,