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 Mar 2014 | Class 2 Medicines Recall (action within 48 hours): Fybogel Orange - Reckitt Benckiser Healthcare (UK) Limited (EL (14)A/04)
Reckitt Benckiser Healthcare (UK) Limited is recalling batches of Fybogel Orange due to a potential risk of contamination with metal particles.
06 Mar 2014 | Class 2 Medicines Recall (action within 48 hours): Viread 245 mg Film-Coated Tablets - Gilead Sciences Limited (EL (14)A/03)
Gilead Sciences Limited is recalling specific batches of Viread 245 mg film-coated tablets due to the possible presence of silicone rubber. A failure of equipment used in the manufacture of the active pharmaceutical ingredient formulated in these medicinal product batches may have resulted in damage to silicone gaskets and silicone fragments entering the product in these recalled lots.
17 Feb 2014 | Class 2 Medicines Recall (action within 48 hours): COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops, solution, single-dose container - Merck Sharp & Dohme Limited (EL (14)A/02)
Merck Sharp and Dohme is recalling specific batches of COSOPT Preservative-Free, 20mg/ml +5mg/ml, eye drops solution due to an increase in the number of adverse events and product complaints relating to difficulties with administration received following the introduction of this ‘winged’ presentation in July 2013.
08 Jan 2014 | Class 4 Medicines Recall (Caution in Use): Irbesartan / Hydrochorothiazide Teva 300/12.5mg and 300/25mg film-coated tablets - Teva UK Ltd (EL (14)A/01)
Teva UK Ltd has informed MHRA that an incorrect dosing instruction is present in the Patient Information Leaflet for Irbesartan / Hydrochorothiazide, Teva strength combinations 300/12.5 mg & 300/25 mg.
23 Dec 2013 | Class 2 Medicines Recall (action with 48 hours): Irbesartan 300mg Film-coated Tablets - Accord Healthcare Limited (EL (13)A/32)
Accord Healthcare Limited are recalling a batch of Irbesartan 300mg film-coated tablets because the blister foil on a small number of blisters is incorrectly labelled as Irbesartan 150mg.
17 Dec 2013 | Class 2 Medicines Recall (action within 48 hours): Methotrexate 25mg/ml Injection, 1 x 2ml - Teva UK Limited (EL (13)A/31)
Teva UK Limited is recalling a batch of Methotrexate 25mg/ml Injection, 1 x 2ml because there have been a small number of reports of damaged vials and there are concerns, therefore, that there is potential for a lack of sterility assurance.
13 Dec 2013 | Class 2 Medicines Recall (action within 48 hours): Tixylix® liquid medicines - Novartis Consumer Health UK Ltd (EL (13)A/30)
Novartis Consumer Health UK Ltd have been alerted to a potential manufacturing fault with the tamper seal on some Tixylix® liquid medicines which might result in small pieces of plastic being found in the medicine.
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.