A carton labelling error affecting the 60mg dose strength of denosumab injection has prompted the UK’s regulatory response, with the MHRA classifying the defect as Class 4—representing the lowest risk level within its medicines defect classification system. The error involves outer carton text incorrectly referencing skin application rather than subcutaneous injection.
Critically, the MHRA’s risk assessment confirms that product safety remains uncompromised. Internal labelling on both vials and pre-filled syringes carries the correct subcutaneous injection instructions, ensuring that healthcare professionals and trained patients receive accurate administration guidance from the primary product labels.
This distinction between outer carton defects and actual product labelling underscores why the regulatory agency assigned the minimal risk classification. Healthcare facilities receiving affected Ponlimsi batches should maintain standard dispensing protocols while noting the carton discrepancy for inventory records.
Read the full article on GMJ Newsroom.
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