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 a Drug Alert is issued. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product.
Drug Alerts relating to theatre practitioners
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01 Apr 2009 | Class 4 Drug Alert (Caution in use): CP Pharmaceuticals/Wockhardt UK - CP Multiparin / Monoparin products (Wockhardt Heparin Sodium products) - EL (09)A/08 Rev 1
A very low level (0.6%) of over sulphated chondroitin sulphate (OSCS) has recently been identified in the active raw material used in the manufacture of 31 batches of CP Pharmaceuticals and Wockhardt UK heparin sodium injections distributed in the UK. EL (09)A/08 Rev 1 replaces EL (09)A/08 which was issued on 31 March 2009.
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24 Apr 2008 | Class 4 Drug Alert (Caution in Use): Low molecular weight heparin - Enoxaparin Sodium ("Clexane") pre-filled syringes
We have recently been informed that some batches of enoxaparin sodium (Clexane) pre-filled syringes with low levels of over-sulphated-chondroitin-sulphate (OSCS) have been distributed in the UK over a period of 4 to 6 weeks.
