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Recall Enforment Report D-0665-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by AbbVie Inc., originally initiated on 09-16-2024 for the product 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 The product was recalled due to lack of assurance of sterility: the impacted lots may contain a breach in the tube seal.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0665-202409-16-202410-02-2024Class II763,426 tubesRefresh 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: 300230312042Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.Ongoing
D-0664-202409-16-202410-02-2024Class II2,473,563 tubesRefresh 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,Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.Ongoing