Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever ...
FDA Recall #D-0065-2021 — Class III — October 22, 2020
Product Description
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120 mL), Berry Flavor, Distributed by Chalkboard Health Inc. Princeton, NJ 08540 getfluenthealth.com Made in India. NDC 79395-003-92
Reason for Recall
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Recalling Firm
Aurobindo Pharma USA Inc. — East Windsor, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
7440 bottles
Distribution
NJ
Code Information
Lot # BO1020080AA3, EXP 7/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated