Recalls / Class III
Class IIID-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
- Brand name
- Childrens Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDC
- 79395-003
- FDA application
- ANDA209179
- Affected lot / code info
- Lot # BO1020080AA3, EXP 7/2023
Why it was recalled
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Chalkboard Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 7440 bottles
- Distribution pattern
- NJ
Timeline
- Recall initiated
- 2020-10-22
- FDA classified
- 2020-11-05
- Posted by FDA
- 2020-11-11
- Terminated
- 2023-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0065-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.