FDA-Drug2020-11-11Class III

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

Aurobindo Pharma USA Inc.
Hazard

Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.

Sold states
NJ
Affected count
7440 bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0065-2021

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