Medicines Management | Drug Alerts
Manufacturers and importers are obliged to report to the Medicines & Healthcare Products Regulatory Agency (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'.”
East Midlands Drug Alert/Recall scheme (revised October 2015)