A medicines recall has been issued for specific batches of Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension (CD Pharma Ltd), following notification of a labelling error by the manufacturer.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a drug alert after CD Pharma Ltd identified an error on the outer carton of several batches.
While the total active content statement on the packaging is correct, the delivered dose content statement is incorrect. The quality of the medicine is not affected and all other details on the carton are correct.
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The incorrect statement reads: ‘Each metered dose (ex-valve) contains 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate.’
The correct statement should read: ‘Each metered dose (ex-valve) contains 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 micrograms of fluticasone propionate and 9 micrograms of formoterol fumarate dihydrate.’
Four batches are affected:
- 270185-24062FA-30424 (expiry 30 Jun 2026,120 actuations, first distributed 30 Jun 2025)
- 270186-24065FA-30443 (expiry 30 Jun 2026, 120 actuations, first distributed 04 Jul 2025)
- 270774-24082FB-30444 (expiry 31 Jul 2026, 120 actuations, first distributed 04 Jul 2025)
- 269881-24064FA-30425 (expiry 30 Jun 2026, 120 actuations, first distributed 04 Jul 2025)
Pharmacy teams are advised to stop supplying the affected batches immediately, quarantine all stock, and return it to their supplier using the approved process.
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The alert added: ‘Patients who are taking Flutiform 250 micrograms / 10 micrograms per actuation pressurised inhalation, suspension should continue to take the medication as prescribed by their healthcare professional.
‘This issue only impacts the statement related to the delivered dose and the other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct.
‘This is a wholesale and pharmacy level recall that will be actioned by a healthcare professional.
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‘There is no quality issue with the product and patients can continue to take their medicine as prescribed.
‘Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.’
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