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Making medicines and medical devices safer

Defective medicines

Medicines that are not of an acceptable quality

Defects in medicines may relate to quality issues with the product itself, the packaging, e.g. carton and blister or other packaging components such as the patient information leaflet. MHRA minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, regulatory authorities and users.

Where a defective medicine is considered to present a risk to public health, the company or manufacturer as appropriate, is responsible for recalling any affected batch(es) or, in rare cases, removing all batches of the product from the market.  MHRA normally supports this action by issuing a Medicines Recall/Notification to healthcare professionals. Other regulators and countries may be notified of a recall by the issue of a Rapid Alert notification.

If a member of the public has reason to believe that their medicine is not of an acceptable quality they should report it to the Yellow Card scheme as soon as possible. You may also with to consult with a doctor or a pharmacist who can also report it to the MHRA using the Yellow Card scheme.

Further information about defective medicines can be found within the guide to defective medicinal products.