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
12 Dec 2013 | Class 4 Drug Alert (Caution in Use): Matrifen 100 micrograms/hour Transdermal Patch, Teva UK Livery - Takeda UK Limited (EL (13)A/29)
Takeda UK Limited has informed us that there is an error in the text on the pouch for batches of Matrifen 100 micrograms/hour Transdermal Patches distributed since 25 May 2013 in Teva UK livery.
09 Dec 2013 | Class 2 Medicines Recall (action within 48 hours): Jext 300 and 150 micrograms solution for injection in pre-filled pens - ALK-Abelló A/S (EL (13)A/28)
ALK-Abelló Ltd is recalling batches of Jext 300 and 150 micrograms solution for injection in pre-filled pens to patient level due to a potential problem with delivery of the dosage following activation of the auto injector has been identified.
05 Dec 2013 | Class 4 Drug Alert (Caution in Use): 8.4% w/v Sodium Bicarbonate - B. Braun Melsungen AG - PL 03551/0069
This alert has been issued as B. Braun Melsungen AG has informed us that during regular visual inspection of retained samples of Sodium Bicarbonate solutions with bromobutyl stoppers precipitation in solution was observed. The particles have been identified as aluminum salt precipitation.
26 Nov 2013 | Company-led drug recall: Boots Pharmaceuticals liquid medicines - The Boots Company PLC - CLDA (13)A08
A potential manufacturing fault with the tamper seal on some Boots Pharmaceuticals liquid medicines has been identified, which may result in small pieces of plastic being found in the medicine.
29 Oct 2013 | Class 2 Medicines Recall (action within 48 hours): Imigran Injection/Subject - GlaxoSmithKline UK - EL (13)A/26
Glaxo Wellcome UK Limited Trading as GlaxoSmithKline UK are recalling batches of Imigran Injection/Subject to pharmacy, clinic and wholesaler level as a small number of syringes may have needles protruding from the needle shield.
25 Oct 2013 | Class 2 Medicines Recall (action within 48 hours - patient and pharmacy level recall): NovoMix 30 Penfill 100U/ml, 3ml and NovoMix 30 FlexPen 100U/ml, 3ml - Novo Nordisk A/S (EL (13)A/25)
Novo Nordisk A/S is recalling specific batches due to the possibility of a very small number of cartridges within each batch containing too much or too little insulin. We understand that the percentage of cartridges affected is approximately 0.14%.
17 Oct 2013 | Class 2 Medicines Recall (action within 48 Hours): Multiple products - Wockhardt UK Limited (EL (13)A/24)
Following Drug Alert EL(13)A/19 a second Wockhardt manufacturing site in India has been inspected. The inspection identified deficiencies in good manufacturing practice (GMP) and the GMP certificate for this site has also been withdrawn. This Drug Alert has been issued as a result of this inspection.
26 Sep 2013 | Class 2 Medicines Recall (action within 48 hours): Natzon 0.4mg Sublingual Tablets - Morningside Healthcare Limited (EL (13)A/23)
Morningside Healthcare Limited has informed the MHRA that a small number of blisters containing Buprenorphine 8mg Sublingual Tablets from batch number 13D22 have inadvertently been packed in cartons labelled Natzon 0.4mg Sublingual Tablets with the same batch number, 13D22.
16 Sep 2013 | Class 2 Drug Alert (Action Within 48 Hours): Bydureon 2mg powder and solvent for prolonged-release suspension for injection - Eli Lilly Nederland B.V. (EL (13)A/22)
Bristol-Myers Squibb and Astra Zeneca, who, following a recent change of ownership, are now Marketing Authorisation holders for the Bydureon (Exenatide) product licence range, are recalling the above batches of Bydureon to pharmacy, clinic and wholesaler level, following an in-depth review of manufacturing records.
01 Aug 2013 | Class 3 Drug Alert (Action Within 5 Days): Warfarin 3mg Tablets in Teva UK and Lloyds Pharmacy liveries - Teva UK Limited (EL (13) A/21)
Teva UK Limited is recalling stock of Warfarin 3mg Tablets because higher than expected levels of degradation products were detected during routine stability studies.