Childrens Ibuprofen Suspension
FDA Recall NDC 79395-003
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Childrens Ibuprofen (NDC 79395-003). A significant event, classified as Class III, was initiated on Oct 22, 2020 by Chalkboard Health. The reported reason for this action was: "Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Oct 22, 2020
Nov 11, 2020
7440 bottles
Recall Profile & Regulatory Data
Event ID
86567
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
NJ
Termination Date
Apr 04, 2023
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
Batch or Lot Expiration Information
Lot# BO1020080AA3, EXP 7/2023
Affected Packages Involved in this Recall
79395-003-92Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
