Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distri...
FDA Recall #D-0579-2022 — Class II — October 26, 2021
Product Description
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
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
14,868 bottles
Distribution
Nationwide in the USA
Code Information
Batch: 1AK1031, Exp 12/31/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated