Aurobindo Pharma USA Inc. is recalling 7,440 bottles of Fluent Children's Fever + Pain Ibuprofen Oral Suspension (100 mg per 5 mL) because the product is missing the required dosing cups. This berry-flavored medication, sold in 4-ounce bottles, was distributed by Chalkboard Health Inc. and manufactured in India. Without the dosing cup, there is a risk that caregivers may use an incorrect measuring device, leading to inaccurate dosing of the medication for children. Consumers should check their medicine cabinets for the affected bottles and contact their healthcare provider or pharmacist for guidance.
The absence of the included dosing cup significantly increases the risk of a medication error, as caregivers may use household spoons or other non-standard measuring tools that do not provide the precise 5 mL measurement required. This could lead to under-dosing or over-dosing the child, potentially causing ineffective treatment or adverse side effects from too much ibuprofen.
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Sources: FDA iRES · Raw API Response
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