Refresh P.M. recall
FDA recall D-0664-2024 · initiated Sep 16, 2024
AbbVie Inc. recalled Refresh P.M. in Sep 2024 — an FDA Class II recall (D-0664-2024) because Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,473,563 tubes
Details
- 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 company
- Abbvie Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
- Initiated
- Sep 16, 2024
- FDA report date
- Oct 2, 2024
Frequently asked
- Was Refresh P.M. recalled?
- AbbVie Inc. recalled Refresh P.M. in Sep 2024 — an FDA Class II recall (D-0664-2024) because Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Refresh P.M. recalled?
- Per the FDA enforcement record, the reason for recall D-0664-2024 was: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
- Is a recalled Refresh P.M. dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Refresh P.M. are affected?
- Distributed: Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain). The recall covers these lots — 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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0664-2024.