Recall
FDAHealthSeptember 16, 2024

AbbVie Inc. — 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

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
September 16, 2024

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

What's affected?

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
Lot code
387489

Additional details

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.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 763,426 tubes.

View original FDA notice →

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