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Drug FDA Class II Ongoing Contamination / non-sterility

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

AbbVie Inc. Published Oct 2, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AbbVie Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of Sterility Assurance / Tube Seal Breach · primary

Affected products (1)

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

763,426 tubes

Lot codes: 387489
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.

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 16, 2024
  2. Published
    Oct 2, 2024
Recall number
D-0665-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.