Refresh P.m. Ointment
FDA Recall NDC 0023-0240
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 P.m. (NDC 0023-0240). 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
1,154,359 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 P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3.
Batch or Lot Expiration Information
Lot# : 85165, 85228, Exp 05/17; 85244, 85351, 85374, 85397, Exp 06/17; 85561, 85676, 85694, Exp 07/17; 85834, 85977, 85985, 86073, Exp 08/17; 85599, 86290, 86325, 86411, 86427, 86506, 86515, 86517, Exp 09/17; 86746, 86792, 86789, 86809, 86822, 86822A, Exp 10/17; 86932, 87100, 87068, Exp 11/17; 87156, 87261, Exp 12/17; 87493, Exp 01/18; 87494, 87731, Exp 02/18.
Affected Packages Involved in this Recall
0023-0240-21Product
0023-0240-04Product
0023-0667-04Product
0023-0667-21Product
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.
