Manufacturers and importers of medicinal products are obliged to report to the MHRA medicinal product which are defective in quality. Other users, wholesalers and distributors of medicinal products are also encouraged to do this.
The defect, once identified, could result in a recall or restricted supply.
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 (includes out of hours);
Class 2 requires action within 48 hours;
Class 3 requires action within 5 days
Class 4 is the least critical and advises 'caution in use'.
The following information should be recorded for ALL drug alerts:
Drug Alert Details Reference No: ___________________________________
Date: ___________________________
Time of notification from MHRA: ____________________________________
Message taken by: ______________________________________________
Product: ______________________________________________________
Batch No: _____________________________________________________
Product Licence No: _____________________________________________
Action required: ________________________________________________
Reason for recall: _______________________________________________
Date completed: _________________________
Signature: ______________________________
If the drug alert is cascaded, then the following information should also be recorded:
List of those informed;
Time phoned/Time emailed/Time of feedback email
