Drug 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
D-0065-2021
Product summary
- Event
- Event 86567
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7440 bottles
- Official record key
drug-enforcement:D-0065-2021
Official wording
Reason: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Code information: Lot # BO1020080AA3, EXP 7/2023
Distribution pattern: NJ
Derived failure modes
-
Unknown
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.