← FDA ENFORCEMENT
D-0665-2024Class II

AbbVie Inc.

Recalling firm
AbbVie Inc.
Product type
Drug
Status
Ongoing
Report date
2024-10-02
Distribution
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Firm state
IL
Product quantity
763,426 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Product description

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

Code / lot info

Lot: 387489, Exp. Oct 24; 387490, Exp. Jun 25; 390422, Exp. Nov 24; 390424, Exp. Oct 24; 391692, Exp. Jun 25; 391893, Exp. Nov 25; 394822, Exp. Feb 26; 395991, Exp. Mar 26; 397905, 397973, 397974, Exp May 26; 399019, 399254, Exp. Jun 26; 399922, Exp. Jul 26; 408738, Exp. Mar 27; T3911, Exp. Sep 24; T4015, T4031, T4032, T4033, T4108, Exp. Oct 24.

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.