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
03 Sep 2014 | Class 2 medicines recall (action within 48 hours): Motilium 10 10mg Tablets and Motilium Instants10mg Orodispersible Tablets manufactured by McNeil Products Limited (EL (14)A/14)
Johnson & Johnson Ltd., on behalf of the Marketing Authorisation Holder McNeil Products Limited, is
recalling all unexpired stock of the above products following a Europe-wide review of the safety and
efficacy of all domperidone products.
13 Aug 2014 | Class 2 medicines recall (action within 48 hours): Idarubicin 1mg/ml injection 5 & 10 ml manufactured by Teva UK Limited (EL (14)A/13)
Teva UK Limited is recalling, as a precautionary measure, two batches of Idarubicin 1mg/ml injection following discovery of a red precipitate during stability testing under cold storage conditions.
28 Jul 2014 | Class 2 medicines recall (action within 48 hours): Buccolam Oromucosal Solution manufactured by ViroPharma SPRL (EL (14)A/12)
ViroPharma SPRL is recalling specific batches of Buccolam Oromucosal Solution, listed in the attached appendix, following a routine inspection of the company’s contract manufacturing site in the UK.
22 Jul 2014 | Class 2 medicines recall (action within 48 hours): Amoxicillin Sodium 500mg Powder for Solution for Injection manufactured by Wockhardt UK Ltd (EL (14)A/11)
Further to the Class 4 ‘caution in use’ Alert issued on 9 July 2014, ref. EL (14)A/09, Wockhardt UK Ltd has received a small number of additional reports of injection site reactions in both paediatrics and adults. As a precaution, some batches of the 500mg presentation are now being recalled.
16 Jul 2014 | Class 2 medicines recall (action within 48 hours): Midazolam Buccal Liquid 10mg / 1ml, 5ml manufactured by Penn Pharma, distributed in Quantum Pharmaceutical livery (EL (14)/A10)
Specific batches of Midazolam Buccal Liquid 10mg / 1ml, 5ml are being recalled because the screw caps on some units have not been correctly placed during manufacture. This may result in evaporation of the aqueous component of the product and a consequent increase in the concentration of Midazolam.
09 Jul 2014 | Class 4 Drug Alert (Caution in Use): Amoxicillin Sodium 250mg, 500g, & 1mg Powder for Solution for Injection, manufactured by Wockhardt UK Ltd (EL (14)A/09)
Wockhardt UK Ltd are asking all healthcare professionals treating neonates and infants not to use Wockhardt Amoxicillin Sodium Powder for Solution for Injection (all batches) in such patients until further notice.
19 Jun 2014 | Class 2 Medicines Recall (action within 48 hours): Fybogel Hi-Fibre and Fybogel Orange manufactured by Reckitt Benckiser Healthcare (UK) Limited (EL (14)A/08)
Reckitt Benckiser Healthcare (UK) Limited is recalling a further two batches of Fybogel due to a potential risk of contamination with metal particles.
18 Jun 2014 | Class 2 Medicines Recall (action within 48 hours): Clarithromycin 500mg Powder for Solution for Infusion in Agila livery manufactured Strides Arcolab International Limited (EL (14)A/07)
Mylan is recalling all remaining stock of the above batches on behalf of Strides Arcolab International Limited due to the potential for small particles of white material to be present in individual vials.
12 Jun 2014 | Class 2 Medicines Recall (action within 48 hours): Vancomycin Powder for Concentrate for Solution for Infusion manufactured by Actavis Group PTC ehf (EL (14)A/06)
Actavis is recalling all remaining stock of specific batches to hospital ward, pharmacy, clinic and wholesale level. This is due to the potential for small particles of fibre material and glass to be present in individual vials, identified by Actavis’ third party manufacturer.
04 Jun 2014 | Class 1 Medicines Recall (Action Now – including out of hours): Lipid Phase only of Parenteral Nutrition manufactured by ITH Pharma Limited (EL (14)A/05)
ITH Pharma Ltd is recalling specific batches of Lipid Phase Parenteral Nutrition from specific hospitals.