MHRA Response to contaminated paediatric medicines – On the 7th of October The Medicines and Healthcare products Regulatory Agency (MHRA) released a response to contaminated paediatric medicines identified by the WHO region of Africa. Although the four products referred to in the WHO Medical Product Alert are not authorised for use in the UK and their active ingredients are not used in any products authorised for the UK market the notification was still noteworthy and show that the safety of the medicines used by patients is the MHRAs highest priority.
The MHRA response states that the contaminated cough syrups, namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, are “substandard products which are unsafe and their use, especially in children, may result in serious injury or death. If you are unsure, please check with your pharmacist.” Following laboratory analysis of samples from each of the products it was confirmed that they contained unacceptable quantities of contaminants, diethylene glycol and ethylene glycol. Upon publishing of the notice by the products had been found in Gambia, however may have been distributed further. The manufacturer of the products Maiden Pharmaceuticals are not an Marketing Authorisation Holder/API Manufacturer listed on any licences in the United Kingdom and it was thus determined that no licensed UK medicinal products are likely to be impacted.
The issuing of this notification by MHRA shows the potential impact and risk that products with quality concerns may have not only on the UK supply chain but globally and the importance of compliance with Good Distribution Practice, Good manufacturing Practice and the relevant regulatory authorities to ensure that the quality and integrity of medicinal products are maintained throughout the supply chain.
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