Recalls / Class II

Class IID-0664-2024

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,

Affected lot / 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

Why it was recalled

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

Recalling firm

Firm

AbbVie Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 N Waukegan Rd, North Chicago, Illinois 60064-1802

Distribution

Quantity

2,473,563 tubes

Distribution pattern

Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)

Timeline

Recall initiated

2024-09-16

FDA classified

2024-09-23

Posted by FDA

2024-10-02

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0664-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.