Topcare Infants Pain And Fever Suspension
FDA Recall NDC 36800-946
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 Topcare Infants Pain And Fever (NDC 36800-946). A significant event, classified as Class II, was initiated on Nov 01, 2013 by Topco Associates Llc. 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
108,828 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, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever acetaminophen suspension liquid, Distributed by: Wal-Mart Stores, Inc., Bentonville, AZ 72716, NDC 49035-946-16, UPC 0 78742 09060 3; b) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-576-16, UPC 0 96295 12093 6; c) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-946-16, UPC 0 36800 34645 1; d) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0946-16, UPC 3 11917 13225 9; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-946-16, UPC 0 41260 35832 6
Batch or Lot Expiration Information
Lot# : 3JK0653, Exp 07/15; 3JK0433, Exp 07/15; 3KK0817, Exp 08/15; 3JK0673, Exp 08/15; 3KK0494, Exp 08/15; 3KK0360, Exp 08/15
Affected Packages Involved in this Recall
49035-946-10Product
49035-946-16Product
36800-946-16Product
36800-946-10Product
37205-576-16Product
0363-0946-16Product
30142-946-16Product
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.
