Pain And Fever Suspension
FDA Recall NDC 37808-161
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 37808-161). A significant event, classified as Class II, was initiated on Nov 01, 2013 by H E B. 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
35,136 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, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7
Batch or Lot Expiration Information
Lot# : 3HK0671, Exp 06/15; 3JK0610, Exp 07/15; 3KK0606, Exp 08/15
Affected Packages Involved in this Recall
37808-161-16Product
37205-577-16Product
0363-0161-16Product
30142-161-16Product
51334-161-16Product
55316-161-16Product
62011-0002-1Product
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.
