Status
Ongoing
Drug Enforcement D-0664-2024
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 P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,
- Product quantity
- 2,473,563 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-0664-2024
- Event ID
- 95332
- Recall initiation date
- September 16, 2024
- Center classification date
- September 23, 2024
- Code info
- Lot: 387392, 387393, 387394, Exp. Feb 25; 387395, 388729, 388730, 388731, 388732, 390391, 390404, Exp. Apr 25; 391688, 391734, Exp. Oct 25; 392616, 392620, Exp. Dec 25; 392987, 393560, Exp. Jan 26; 394816, 394821, Exp. Nov 25; 394927, 394929, Exp. Feb 26; 395713, 395992, 396815, Exp. Mar 26; 396816, 397248, 397315, Exp. Apr 26; 397316, 397774, 397775, 397776, 398436, 398437, Exp. May 26; 398621, 398643, 398739, 398944, 399001, 399255, 399270, 399271, Exp. Jun 26; 399798, 399806, 400003, Exp. Jul 26; 408668, 408723, 408737, 408853, 408895, Exp. Apr 27; 409121, 409142, Exp. May 27; 409261, Exp. Apr 27; T4534, T4535, T4591, T4592, Exp. Dec 24; T4660, T4661, T4696, T4697, T4709, T4772, T4773, Exp. Jan 25; T4844, T4845, Feb 25
- More code info
- —