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| The United Kingdom: Class 2 Medicines Recall: Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension, CD Pharma Ltd (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that CD Pharma Ltd have notified the MHRA of an error on the outer carton of 4 batches of Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension (fluticasone propionate/formoterol fumarate) (batch number: 270185-24062FA-30424, 270186-24065FA-30443, 270774-24082FB-30444, 269881-24064FA-30425). While the total active content statement is correct, the delivered dose content statement is incorrect. This is a wholesale and pharmacy level recall that will be actioned by a healthcare professional.
The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The quality of the medicine is not impacted by the labelling defect.
The product helps to prevent breathing problems such as asthma and helps to stop becoming breathless and wheezy.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-flutiform-250-micrograms-slash-10-micrograms-per-actuation-pressurised-inhalation-suspension-cd-pharma-ltd-el-25-a-slash-35
In Hong Kong, Flutiform 250 Microgram/10 Microgram Per Actuation Pressurised Inhalation Suspension (HK-62090) is a pharmaceutical product registered by DKSH Hong Kong Limited (DKSH). The product is a prescription-only medicine. As confirmed by DKSH, the affected batches have not been imported into Hong Kong.
Ends/Friday, Jul 25, 2025
Issued at HKT 15:00
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