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
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
Lack of Assurance of Sterility