Refresh Lacri-lube Ointment
FDA Recall NDC 0023-0312
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Refresh Lacri-lube (NDC 0023-0312). A significant event, classified as Class II, was initiated on Aug 24, 2015 by Allergan, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Aug 24, 2015
Sep 30, 2015
320,713 tubes
Recall Profile & Regulatory Data
Event ID
72016
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Allergan Sales, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, and Barbados
Termination Date
Apr 19, 2017
Product Description
Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612.
Batch or Lot Expiration Information
Lot# : a) 84746, Exp 04/17; 84987, 85087, Exp 05/17; 85359, Exp 06/17; 85721, Exp 07/17; 86045, Exp 08/17; 86406, Exp 09/17; 86594, Exp 10/17; 87021, Exp 11/17; and b) 86470, Exp 09/17; 86829, Exp 10/17; 87105, Exp 11/17
Affected Packages Involved in this Recall
0023-0312-04Product
0023-0312-07Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
