FDA recall D-0664-2024

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-09-16

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2024