FDA recall D-0065-2021

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 for recall

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

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2020-10-22

Report date

2020-11-11

Termination date

2023-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

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