Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this.
Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'drug alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.
Recent Drug Alerts relevant to radiologists
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11 Jun 2008 | Class 3 Drug Alert (Action within 5 days): Enoxaparin sodium ("Clexane") pre-filled syringes - EL(08)A/7
The letter attached to Drug Alert EL(08)A/5 published on 6 June 2008 listed four batch numbers of uncontaminated 40mg Clexane pre-filled syringes recommended for supply to pregnant patients. The list included batch 04251 which we now understand has never been produced or distributed.
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05 Feb 2007 | Class 4 Drug Alert (Caution in Use): BOC Ltd - Compressed Medical Nitrous Oxide - EL(07)A/03
Following our Drug Alert EL(07)A/02, issued on 23 January 2007 for AZ size aluminium medical oxygen cylinders, BOC have now informed us that a small number of medical nitrous oxide AZ cylinders may also present a danger when used in MRI units.
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24 Jan 2007 | Class 4 Drug Alert (Caution in Use): BOC Ltd - Compressed Medical Oxygen - EL(07)A/02
This is for targeted distribution to NHS and private hospital pharmacists and MRI units to address a specific hazard in MRI units. The content is not relevant to GPs, retail pharmacies and wholesalers and has not been supplied to these groups.
