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'.
Obstetrics and gynaecology-related Drug Alerts
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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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12 Feb 2009 | Class 2 Drug Alert (action within 48 hours): Quadrant Pharmaceuticals Limited - Clexane 40mg/0.4ml pre-filled syringe (Parallel Import) (Enoxaparin 40mg/0.4ml pre-filled syringe) - EL (09)A/04
Quadrant Pharmaceuticals Limited is recalling a batch of Clexane 40mg/0.4ml because it is contaminated with a low level of Over Sulphated Chondroitin Sulphate (OSCS).
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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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06 Jun 2008 | Class 4 Drug Alert (Caution in use): Enoxaparin Sodium (Clexane) pre-filled syringes - Supply update and advice to prescribers on shortage of 150mg syringes and use in pregnancy
Further to the drug alerts issued on 24 April and 9 May concerning enoxaparin (Clexane) pre-filled syringes contaminated with over-sulphated-chondroitin sulphate (OSCS), this provides an update on the supply situation and clinical advice.
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09 May 2008 | Class 4 Drug Alert (Caution in Use): Parallel imports of low molecular weight heparin - Enoxaparin sodium (Clexane) pre-filled syringes
We wish to advise Parallel Importers that we are concerned about higher levels of contamination in some lots of Clexane syringes which have been supplied to some overseas markets. We do not wish to see these batches supplied to the UK market as parallel imports.
