October 2020 FDA Recall Childrens Ibuprofen by Aurobindo Pharma Usa Inc.
D-0065-2021 - Labeling Not Elsewhere Classified

This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on October 22, 2020 for the product Childrens Ibuprofen. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed in NJ and the recall is currently terminated.

Recall Number: D-0065-2021

Reason for Recall
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Initiated
10-22-2020
Reported
11-11-2020
Quantity
7440 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86567
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-04-2023
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# BO1020080AA3, EXP 7/2023

Affected Packages Involved in this Recall

79395-003-92 Childrens Ibuprofen