Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-pa...
FDA Recall #D-005-2014 — Class II — November 1, 2013
Product Description
Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain & Fever acetaminophen, Distributed by Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-766-16, UPC 0 36800 34650 5; b) Meijer Infants' Pain & Fever acetaminophen oral suspension, Dist. By Meijer Distribution, Inc., 2929 Waler Ave. NW, Grand Rapids, MI 49544, NDC 41250-766-16, UPC 7 13733 31403 9; c) Rite Aid infants' fever reducer & pain reliever oral suspension, Distributed By: Rite Aid, 30 hunter Lane, Camp Hill, PA 17011, UPC 0 11822 35341 0; d) Walgreens infants' Dye-Free Pain & Fever acetaminophen suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0766-16, UPC 3 11917 13223 5; e) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-766-16, UPC 0 41260 35830 2
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.
Recalling Firm
L. Perrigo Co. — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
27,504 bottles
Distribution
Nationwide
Code Information
Lot #: 3GK0704, Exp 04/15; 3JK0597, Exp 08/15; 3KK0359, Exp 08/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.