Refresh P.M. Eye Ointment (AbbVie) – Tube Seal Breach (2024)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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,
Brand
AbbVie Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
AbbVie Inc. is recalling Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3 due to Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026