Recalls / Class II

Class IID-0665-2024

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

Affected lot / code 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.

Why it was recalled

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

Recalling firm

Firm

AbbVie Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 N Waukegan Rd, North Chicago, Illinois 60064-1802

Distribution

Quantity

763,426 tubes

Distribution pattern

Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)

Timeline

Recall initiated

2024-09-16

FDA classified

2024-09-23

Posted by FDA

2024-10-02

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0665-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.