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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09 Feb 2012 | Class 3 Drug Alert: Teva UK Limited - Alendronic Acid 10mg Tablets - EL(12)A/06
During non-routine testing 10 months after manufacture, some samples were found to be marginally out of specification for assay. This finding is not expected to impact on patient safety at this stage but there are concerns about potential effects on potency of the batch during the remainder of the shelf-life.
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07 Feb 2012 | Class 4 Drug Alert: Updated information for our alerts EL(11)A/32 of 21 December 2011 and EL(12)A/01 of 11 January 2012 - EL(12)A/05
Following our alerts EL(11)A/32 issued on 21 December 2011 and EL(12)A/01 issued on 11 January 2012, B.Braun Medical Ltd have advised us that they need to release additional batches of the above NuTRIflex Lipid products which may contain particulates and should be subject to the same additional filtration process previously recommended during infusion.
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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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15 Dec 2011 | Class 2 Drug Alert (Action Within 48 Hours): Teva UK Ltd - Prednisolone EC 2.5mg and 5mg Tablets in blister packs - EL (11)A/31
Teva UK Limited is recalling all remaining stock of four batches of Prednisolone EC 2.5 mg and 5 mg tablets in blister packs from hospitals, clinics, pharmacies and wholesalers as elevated levels of related substances have been detected early in the shelf-life during routine stability testing.
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23 Nov 2011 | Class 2 Drug Alert (Action within 48 hours): Pierre Fabre Médicament - Busilvex 6mg/ml concentrate for solution for infusion - EL (11)A/30
Pierre Fabre Limited is recalling all remaining stock of specific batches of Busilvex 6mg/ml concentrate for solution for infusion due to concerns that acceptable levels of sterility assurance during manufacture cannot be guaranteed.
