FDA Recall D-0664-2024
AbbVie Inc. · North Chicago, IL
Class II Ongoing 605 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Recall record
- Recall number
D-0664-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Recall initiated
- 2024-09-16
- Classified by FDA Center
- 2024-09-23
- FDA published
- 2024-10-02
- Recalling firm
- AbbVie Inc.
- Firm location
- North Chicago, IL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.