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Class III: unlikely to cause harmTerminated

Aurobindo Pharma Fluent Children's Fever + Pain IBUPROFEN Recall

Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Relie…

Aurobindo Pharma USA Inc. · East Windsor, NJ

Risk level
Class III
Reported by FDA
Nov 11, 2020
Recall ID
D-0065-2021
Check your lot numberHow we source this data

Summary

Aurobindo Pharma recalled Fluent Children's Fever + Pain IBUPROFEN starting Oct 22, 2020. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0065-2021 on Nov 11, 2020. Reason: Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. Status: Terminated.

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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0065-2021, published Nov 11, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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