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 relating to orthopaedics
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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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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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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.
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19 Nov 2007 | Drug safety information: Lumiracoxib - Suspension of UK licences with immediate effect - Further information
Further to the Drug Safety Information and Public Health Link letters of 19 November 2007 (our reference EL(07)A/21), all lumiracoxib products should be returned from Pharmacy level via suppliers within five days of receipt of this letter. This is equivalent to a Class 3 Pharmacy Level recall.
