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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07 May 2013 | Class 4 Drug Alert (Caution in Use): Aurum Pharmaceuticals Limited (trading as Martindale Pharma) - Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - EL 13(A)13 Rev 1
Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed the MHRA that there is a misalignment of the syringe label of pre-filled syringe batches.
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02 May 2013 | Class 4 Drug Alert (Caution in Use): Ativan Injection 4mg/ml - Pfizer Limited - EL (13)A/14
Pfizer Limited has informed us that during routine testing and subsequent investigation of some unreleased batches of Ativan Injection which had been subjected to automated visible inspection during manufacture, a very small number of ampoules containing glass particles were identified. Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
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29 Apr 2013 | Class 4 Drug Alert (Caution in Use): Aurum Pharmaceuticals Limited (trading as Martindale Pharma) - Adrenaline (Epinephrine) Injection 1:10,000 1mg/10ml, Amiodarone Injection 30mg/ml, Ephedrine Hydrochloride Injection 3mg/ml - EL 13(A)13
Aurum Pharmaceuticals Limited (trading as Martindale Pharma) has informed the MHRA that there is a misalignment of the syringe label of pre-filled syringe batches.
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24 Apr 2013 | Class 3 Drug Alert (Action Within 5 days): Diazepam 2mg Tablets - Teva UK Limited - EL 13(A)12
Teva UK Limited is recalling all remaining stock of the specified batches of Diazepam because the results of assays carried out during routine stability studies did not comply with the required specification.
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02 Apr 2013 | Class 2 Drug Alert (Action Within 48 Hours): Miacalcic 200 IU Nasal Spray Solution - Novartis Pharmaceuticals UK Ltd - EL 13(A)11
All unexpired stock of Miacalcic 200 IU Nasal Spray Solution is being recalled to pharmacy, clinic and wholesaler level irrespective of batch number and expiry date. Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
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20 Mar 2013 | Class 4 Drug Alert (Caution in Use): Circadin 2mg prolonged-release tablets - RAD Neurim Pharmaceuticals EEC Limited - EL (13)A/10
Flynn Pharma Limited, distributors of Circadin 2mg prolonged-release tablets, has informed the MHRA that there is an error in the patient information leaflet (PIL) supplied in batches of this product distributed since 11 February 2013.
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06 Mar 2013 | Class 4 Drug Alert (Caution in Use): Cytarabine Injection 100mg/ml (1g/10ml) - Hospira UK Limited - EL (13)A/09
Hospira UK Limited has informed the MHRA that it has identified the potential for crystallisation in batch Z031966AA of Cytarabine Injection 100mg/ml (1g/10ml). Healthcare Professionals are asked to visually inspect vials for particulate matter prior to use. If crystals are found the product should not be used.
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05 Mar 2013 | Class 2 Drug Alert (Action Within 48 Hours): Mylan - Montelukast 5 mg Chewable Tablets - EL (13)A/08
Mylan are recalling all remaining stock of Montelukast 5 mg Chewable Tablets batch 8009003 to Pharmacy, clinic and wholesaler level, due to an error on the carton..
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27 Feb 2013 | Class 2 Drug Alert (Action Within 48 Hours): Sanofi-aventis - Brochlor 1% w/w Eye Ointment - Chloramphenicol - EL (13)A/07
Sanofi-aventis are recalling all remaining stock of these batches to Pharmacy, clinic and wholesaler level, due to an issue with seal integrity and compromised sterility assurance, introduced during the filling process.
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27 Feb 2013 | Class 2 Drug Alert (Action Within 48 Hours): Typharm Limited - GoldenEye 0.15% w/w eye ointment - Dibrompropamidine Isetionate - EL (13)A/06
Cambridge Healthcare Supplies Limited, on behalf of Marketing Authorisation Holder, Typharm Limited are recalling all remaining stock of one batch of of GoldenEye 0.15% w/w eye ointment to pharmacy, clinic and wholesaler level, due to an issue with seal integrity and compromised sterility assurance, introduced during the filling process.
