Drug Enforcement D-006-2014

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

Classification

Class II

Report Date

November 27, 2013

Termination Date

April 15, 2014

Product Information

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
Product quantity
108,828 bottles
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.
Recall initiation reason
—
Initial firm notification
Press Release
Distribution pattern
Nationwide

Location & Firm

Recalling firm
L. Perrigo Co.
Address
515 Eastern Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-006-2014
Event ID
66711
Recall initiation date
November 1, 2013
Center classification date
November 20, 2013
Code info
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
More code info
—