Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Dist...

FDA Recall #D-0584-2022 — Class II — October 26, 2021

Recall #D-0584-2022 Date: October 26, 2021 Classification: Class II Status: Terminated

Product Description

Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16

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

22,140 bottles

Distribution

Nationwide in the USA

Code Information

Batch: 1CK0907, Exp 01/31/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated