Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DIST...
FDA Recall #D-0595-2022 — Class II — October 26, 2021
Product Description
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
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
1,296 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1CK1274, Exp 02/28/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated