Why it was recalled
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # BO1020080AA3, EXP 7/2023
Where it was sold
NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0065-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 22, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 7440 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0065-2021, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86567
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot # BO1020080AA3, EXP 7/2023
- Postal code
- 08520-1401
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0065-2021
- Classification
- Class III
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 7440 bottles
- Termination date
- Apr 4, 2023
- Reason for recall
- Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- NJ
- Recall initiation date
- Oct 22, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2020