Recall: D-0065-2021
Class III - Minor Violations
Class IIIClassification
2020-10-22Initiated
TerminatedStatus
Aurobindo Pharma USA Inc.Firm
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
Reason
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Distribution
NJ
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.