Status
Ongoing
Drug Enforcement D-0665-2024
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Classification
Class II
Report Date
October 2, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 763,426 tubes
- Reason for recall
- Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Location & Firm
- Recalling firm
- AbbVie Inc.
- Address
-
1 N Waukegan Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0665-2024
- Event ID
- 95332
- Recall initiation date
- September 16, 2024
- Center classification date
- September 23, 2024
- 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.
- More code info
- —