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MHRA Recalls Four Batches of Flutiform Inhalers Over Dosage Labelling Error

Pharmacies have been directed to isolate the mislabelled cartons following the regulator’s move to ensure asthma patients receive accurate dosing.

Overview

  • The MHRA recalled the inhalers after CD Pharma Ltd flagged that four production batches’ outer cartons misstated the delivered dose per actuation.
  • The labelling error underrepresents each puff as delivering roughly half the intended fluticasone and formoterol amounts, despite the inhalers containing the correct 250 micrograms/10 micrograms dosage.
  • Pharmacies must cease dispensing the affected batches and return quarantined stock to suppliers through approved channels without issuing the inhalers to patients.
  • Officials have confirmed the packaging fault does not affect the medicine’s quality or its efficacy in controlling asthma symptoms.
  • Patients are advised to continue using their prescribed inhaler and to report any suspected adverse reactions via the MHRA Yellow Card Scheme.