Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DI...
FDA Recall #D-0598-2022 — Class II — October 26, 2021
Product Description
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16
Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling Firm
Perrigo Company PLC — Allegan, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
68,688 bottles
Distribution
Nationwide in the USA
Code Information
Batches: 1FK1027, 1FK1184, 1EK1046, Exp 02/28/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated