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 cardiology.
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23 Dec 2009 | Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals - Amiodarone Hydrochloride 50 mg/ml concentrate for solution for injection or infusion - EL (09)A/36
Aurum Pharmaceuticals has informed us that particles have been found in some ampoules of the above product.
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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 Dec 2008 | Class 2 Drug Alert (Action within 48 hours): Genus Pharmaceuticals Limited - Tensipine MR 10mg tablets - EL (08)A/21
The manufacturers have informed us that in a very small number of cases, blisters containing Tensipine MR 10mg from batch 28003 have inadvertently been packed in 20mg cartons.
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20 Aug 2008 | Class 4 Drug Alert (Caution in use): Baxter Healthcare Ltd - Brevibloc injection 10mg/ml vials - EL(08)A/12
We have been informed that batches of Brevibloc vials, distributed since the start of 2008, have been distributed with an error in the Technical Leaflet (TL) document supplied in the pack.
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22 Jan 2008 | Class 3 Drug Alert (action within 5 days): Metwest Pharmaceuticals Ltd - Simvastatin Tablets 10mg - EL(08)A/1
Metwest Pharmaceuticals Ltd are recalling a batch of Simvastatin Tablets 10mg because the blister foil is incorrectly labelled as Simvastatin 20mg. All other labelling is correct and tablets present in the blisters are 10mg strength.
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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.
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01 Nov 2007 | Class 2 Drug Alert (action within 48 hours): Chatfield Pharmaceuticals Ltd - Atenolol 25, 50 & 100mg Tablets - EL(07)A/19
Chatfield Pharmaceuticals Ltd are recalling any remaining stock of the above products due to multiple Good Manufacturing Practice (GMP) failures at their contract manufacturer.
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15 Oct 2007 | Class 2 Drug Alert (action within 48 hours): Bristol Laboratories Ltd - Warfarin Tablets 1mg - EL(07)A/16
Bristol Laboratories Ltd are voluntarily recalling certain batches of Warfarin 1mg tablets due to these products not complying with the voluntary code of practice.
