Pain And Fever Suspension
FDA Recall NDC 41250-590
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 Pain And Fever (NDC 41250-590). A significant event, classified as Class II, was initiated on Nov 01, 2013 by Meijer Distribution Inc. The reported reason for this action was: "Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings."
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
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Nov 01, 2013
Nov 27, 2013
143,892 bottles
Recall Profile & Regulatory Data
Event ID
66711
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
L. Perrigo Co.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 15, 2014
Product Description
Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by SUPERVALU Inc., Eden Prairie, MN 55344, NDC 41163-590-16, UPC 0 41163 48657 7; b) Up & Up dye free infants' pain and fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-590-16, UPC 3 70030 62529 1; c) equate Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-590-16, UPC 6 81131 00185 4; d) Meijer Infants' Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, NDC 41250-590-16, UPC 7 13733 31376 6; e) Walgreens infants' Dye-Free Pain & Fever acetaminophen oral suspension, 2 FL OZ (59 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0590-16, UPC 3 11917 13222 8; f) Kroger Infants' Pain & Fever suspension liquid, 4 FL OZ (118 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-26, UPC 0 41260 36738 0; g) Kroger Infants' Pain & Fever acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-590-16, UPC 0 41260 35829 6; h) Publix Infants' painrelief acetaminophen suspension liquid, 2 FL OZ (59 mL), Distributed By Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 55062-590-16, UPC 0 41415 39573 2; i) CareOne Infants' Dye-Free Pain Relief acetaminophen suspension liquid, 2 FL OZ (59 mL) bottle, Distributed By Foodhold U.S.A., LLC, Landover, MD 20785, NDC 41520-590-16, UPC 3 41520 31006 5; j) Harmon FaceValues Infants' Pain & Fever acetaminophen suspension Liquid, 2 FL OZ (59 mL), Distributed by Harmon Stores, Inc., 650 Liberty Ave., Union, NJ 07083 USA, UPC 3 70030 51018 4
Batch or Lot Expiration Information
Lot# 2 FL OZ
Lot# : 3HK0564, Exp 06/15; 3HK0672, Exp 06/15; 3JK0594, Exp 07/15; 3JK0595, Exp 08/15; 3KK0815, Exp 08/15; 4 FL OZ
Lot# : 3GK0645, Exp 06/15
Affected Packages Involved in this Recall
41250-590-16Product
41250-590-10Product
30142-590-16Product
30142-590-26Product
41163-590-16Product
11673-590-16Product
49035-590-16Product
0363-0590-16Product
55062-590-16Product
41520-590-16Product
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.
