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Class II: temporary or reversible health riskTerminated

L. Perrigo Acetaminophen suspension liquid Recall

Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with…

L. Perrigo Co. · Allegan, MI

Risk level
Class II
Reported by FDA
Nov 27, 2013
Recall ID
D-003-2014
Check your lot numberHow we source this data

Summary

L. Perrigo recalled Acetaminophen suspension liquid starting Nov 1, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-003-2014 on Nov 27, 2013. Reason: Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings. Status: Terminated.

Why it was recalled

Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-003-2014
Classification
Class II
Status
Terminated
Recall initiated
Nov 1, 2013
FDA report date
Nov 27, 2013
Quantity
143,892 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
L. Perrigo Co.

Original FDA data

Every field from FDA enforcement report D-003-2014, exactly as published.

Show all FDA fields
City
Allegan
State
MI
Status
Terminated
Country
United States
Event ID
66711
Address
515 Eastern Ave
Code information
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
Postal code
49010-9070
Report date
Nov 27, 2013
Product type
Drugs
Recall number
D-003-2014
Classification
Class II
Recalling firm
L. Perrigo Co.
Product quantity
143,892 bottles
Termination date
Apr 15, 2014
Reason for recall
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Nov 1, 2013
Initial firm notification
Press Release
Center classification date
Nov 20, 2013

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-003-2014, published Nov 27, 2013. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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