This section of the site gives details of MHRA drug alerts issued since 29 October 2001.
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'.
Latest Drug Alerts
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24 Jan 2012 | Company-led drug recall: Gaviscon Advance Aniseed Suspension, 500ml bottles - Reckitt Benckiser (UK) Ltd - CLDA(12)A/01
Reckitt Benckiser (UK) Ltd has recalled this product as a small portion of two batches of this product has been exposed to cold temperatures, which has resulted in non reversible solidification of the contents.
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23 Jan 2012 | Drug safety information - MHRA safety information for Vigantoletten (1000 IU Colecalciferol) Tablets - (EL (12)A/04)
This unlicensed product is imported in significant quantities into the UK. Although importers are advised that the prescriber must be made aware that Vigantoletten tablets contain soya oil, and are contraindicated for patients with allergies to this ingredient, it has come to the attention of the MHRA that not all users may be aware of these safety issues. Recipients are asked to bring this information to the attention of relevant professionals.
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23 Jan 2012 | Drug safety information: Dekristol (20,000 IU Colecalciferol) Capsules - EL (12)A/03
Dekristol (20,000 IU Colecalciferol) Capsules, an unlicensed product, is imported in significant quantities to the UK. Although importers are advised that the prescriber may be made aware that Dekristol capsules contain arachis (peanut) oil, and are contraindicated for patients with allergies to this ingredient, it has come to the attention of the MHRA that not all users may be aware of these safety issues. Recipients are asked to bring this information to the attention of relevant professionals.
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17 Jan 2012 | Class 2 Drug Alert (Action Within 48 Hours) Accord Healthcare Limited - Amoxicillin - EL (12)A/02
Accord Healthcare Limited is recalling a batch of Amoxicillin 500mg Capsules because the blister foil in some packs are incorrectly labelled.
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11 Jan 2012 | Class 4 Drug Alert: Updated information for our alert EL(11)A/32 of 21 December 2011 - EL(12)A/01
Following our alert EL(11)A/32, issued on 21 December 2011, B.Braun Medical Ltd has advised us that additional batches of NuTRIflex Lipid products may contain particulates and should be subject to the same additional filtration process previously recommended during infusion.
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23 Dec 2011 | Class 2 Drug Alert (Action Within 48 Hours): Lundbeck Limited - Clopixol Conc Injection (500mg/ml) - EL (11)A/33
Lundbeck Limited have informed us that they are recalling batches of Clopixol Conc Injection (500mg/ml) this is because there have been a small number of reports of cracked ampoules and there are concerns that sterility assurance cannot be guaranteed.
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21 Dec 2011 | Class 4 Drug Alert: B.Braun Medical Ltd - NuTRIflex Lipid products - EL (11)A/32
B.Braun Medical Ltd is issuing advice to filter several batches of NuTRIflex Lipid products due to the possible presence of particulates.
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21 Dec 2011 | Class 4 Drug Alert: B.Braun Medical Ltd - NuTRIflex Lipid plus, plus without electrolytes, special, special without electrolytes and peri - EL (11)A/32
(59Kb)
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21 Dec 2011 | Class 4 Drug Alert: Appendix two - Christmas opening hours for Braun Customer Services
(12Kb)
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21 Dec 2011 | Class 4 Drug Alert: Appendix one - stocklist
(75Kb)
