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Recall Observatory FDA recall evidence

Drug 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

D-0665-2024

September 16, 2024

Class II

Product summary

Firm
AbbVie Inc.
Event
Event 95332
Status
Ongoing
Classification
Class II
Quantity
763,426 tubes
Official record key
drug-enforcement:D-0665-2024

Official wording

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

Code information: 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.

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility