Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Dis
Summary
The FDA issued a Class II for Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Oi by AbbVie Inc.. Reason: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal..
Details
Source
Drug Recall
External ID
D-0665-2024
Action Date
2024-10-02
Status
Ongoing
Category
drug
Product Description
Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042
Lot/Code Info: Lot: 387489, Exp. Oct 24; 387490, Exp. Jun 25; 390422, Exp. Nov 24; 390424, Exp. Oct 24; 391692, Exp. Jun 25; 391893, Exp. Nov 25; 394822, Exp. Feb 26; 395991, Exp. Mar 26; 397905, 397973, 397974, Exp May 26; 399019, 399254, Exp. Jun 26; 399922, Exp. Jul 26; 408738, Exp. Mar 27; T3911, Exp. Sep 24; T4015, T4031, T4032, T4033, T4108, Exp. Oct 24.
Quantity Affected: 763,426 tubes
Reason for Recall
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Distribution
Nationwide in the USA, Foreign Consignees (Austrailia, Canada, Great Britain)
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-16
Company
North Chicago, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
AbbVie Inc. has 6 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AbbVie Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AbbVie Inc. have FDA actions?
AbbVie Inc. has 6 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0665-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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