FDA-Drug2024-10-02Class II

Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042

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
763,426 tubes
Manufactured in
1 N Waukegan Rd, North Chicago, IL, United States
Products
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2024

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