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OTC Dry Eye Ointments Recalled for Sterility Concerns
AbbVie Inc. is recalling more than 3 million tubes of Refresh PM and Refresh Lacri-Lube lubricant eye ointment due to a lack of assurance of sterility. According to the October 2, 2024, US Food and Drug Administration (FDA) Enforcement Report, products from “the impacted lots may contain a breach in the tube seal.”
The recall affects the following products, which were distributed in the United States and to foreign consignees in Australia, Canada, and Great Britain by Allergen, an AbbVie company, Madison, New Jersey:
- Refresh PM (42.5% mineral oil, 57.3% white petrolatum) lubricant eye ointment, in 3.5-gram tubes (UPC code 300230667043), from lots 387392, 387393, and 387394 (Exp. 2/25); 387395, 388729, 388730, 388731, 388732, 390391, and 390404 (Exp. 4/25); 391688 and 391734 (Exp. 10/25); 392616 and 392620 (Exp. 12/25); 392987 and 393560 (Exp. 1/26); 394816 and 394821 (Exp. 11/25); 394927 and 394929 (Exp. 2/26); 395713, 395992, and 396815 (Exp. 3/26); 396816, 397248, and 397315 (Exp. 4/26); 397316, 397774, 397775, 397776, 398436, and 398437 (Exp. 5/26); 398621, 398643, 398739, 398944, 399001, 399255, 399270, and 399271 (Exp. 6/26); 399798, 399806, and 400003 (Exp. 7/26); 408668, 408723, 408737, 408853, and 408895 (Exp. 4/27); 409121 and 409142 (Exp. 5/27); 409261 (Exp. 4/27); T4534, T4535, T4591, and T4592 (Exp. 12/24); T4660, T4661, T4696, T4697, T4709, T4772, and T4773 (Exp. 1/25); T4844 and T4845 (2/25); and
- Refresh Lacri-Lube (42.5% mineral oil, 57.3% white petrolatum) lubricant eye ointment, in 3.5-gram tubes (UPC code 300230312042), from lots 387489 (Exp. 10/24); 387490 (Exp. 6/25); 390422 (Exp. 11/24); 390424 (Exp. 10/24); 391692 (Exp. 6/25); 391893 (Exp. 11/25); 394822 (Exp. 2/26); 395991 (Exp. 3/26); 397905, 397973, and 397974 (Exp. 5/26); 399019 and 399254 (Exp. 6/26); 399922 (Exp. 7/26); 408738 (Exp. 3/27); T3911 (Exp. 9/24); and T4015, T4031, T4032, T4033, and T4108 (Exp. 10/24).
AbbVie voluntarily initiated the recalls on September 16, 2024. The FDA designated them Class II on September 23, 2024, communicating use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Refresh PM and Refresh Lacri-Lube lubricant eye ointments are over-the-counter treatments marketed for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
