FDAClass IIOctober 2, 2024

Refresh P.M recall: Sterility Concern

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,

Why was Refresh P.M recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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,
Recalling firm
AbbVie Inc.
Quantity
2,473,563 tubes
Distribution
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Recall date
October 2, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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