FDA-Drug2024-10-02Class II
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,
AbbVie Inc.
Hazard
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Sold states
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Affected count
2,473,563 tubes
Manufactured in
1 N Waukegan Rd, North Chicago, IL, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0664-2024Don't want to check this manually?
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