Safety Alerts & Recalls

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Recall Tegretol: Safety Warnings Not Included in Patient Information Leaflet
Star Pharmaceuticals Limited is recalling unused stock from select batches of Tegretol Retard 200 mg and 400 mg tablets because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency. The safety warning which should have been included in the PILs for Tegretol Retard under the section titled "Before taking your medicine" or "Take special care with Tegretol Retard" states: 1) A small number of people being treated with anti-epileptics such as Tegretol Retard have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. 2) Serious skin side effects can rarely occur during treatment with Tegretol Retard. This risk can be predicted with a blood sample in people of Chinese and Thai origin. Discuss this with your doctor before taking Tegretol Retard if you are of such origin. Tegretol Retard contains the active ingredient carbamazepine. Please note, other companies may distribute this medicine, but this recall only applies to select batches of Tegretol Retard from Star Pharmaceuticals Limited. For more information and a complete list of recalled batch numbers, please visit: http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON076463
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Recall Olmetec: Safety warnings not included in patient information leaflet
Star Pharmaceuticals Limited is recalling unused stock from a single batch of Olmetec 10 mg tablets because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency. The safety warnings which should have been included in the PILs for Olmetec warn about the risks of taking Olmetec by women who are pregnant or breast feeding. Olmetec contains the active ingredient olmesartan. Please note, other companies may distribute this medicine, but this recall only applies to a single batch of Olmetec from Star Pharmaceuticals Limited. For more information and a complete list of recalled batch numbers, please visit: http://www.mhra.gov.uk/Publications/Safetywarnings/DrugAlerts/CON076463
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Date Published Title Medicine Source
2010-04-01 Recall Tegretol: Safety Warnings Not Included in Patient Information Leaflet Carbamazepine MHRA
2010-04-01 Recall Olmetec: Safety warnings not included in patient information leaflet Olmesartan MHRA
2010-04-01 Recall Innozide: Safety Warnings Not Included in Patient Information Leaflet Enalapril Maleate with Hydrochlorothiazide MHRA
2010-04-01 Recall Frisum: Safety Warnings Not Included in Patient Information Leaflet Frisium MHRA
2010-04-01 Recall Efexor XL: Safety Warnings Not Included in Patient Information Leaflet Venlafaxine MHRA
2010-04-01 Recall Diovan: Safety Warnings Not Included in Patient Information Leaflet Miten MHRA
2010-04-01 Recall Dipexol: Safety Warnings Not Included in Patient Information Leaflet Flupentixol MHRA
2010-04-01 Recall Topamax: Safety Warnings Not Included in Patient Information Leaflet Topiramate MHRA
2010-04-01 Recall Staril: Safety Warnings Not Included in Patient Information Leaflet Fosinopril MHRA
2010-04-01 Recall Neurontin: Safety Warnings Not Included in Patient Information Leaflet Gabapentin MHRA
2010-04-01 Recall Lamictal: Safety Warnings Not Included in Patient Information Leaflet Lamotrigine MHRA
2010-04-01 Recall Innovace: Safety Warnings Not Included in Patient Information Leaflet Enalapril MHRA
2010-04-01 Recall Cozaar: Safety Warnings Not Included in Patient Information Leaflet Losartan MHRA
2010-03-31 Manufacturer Announces Further Delay in Supply of Cerezyme Imiglucerase MHRA
2010-03-31 Manufacturer Announces Further Delay in Supply of Fabrazyme Agalsidase Beta MHRA
2010-03-31 Tysabri: MHRA Publishes Safety Update and Manufacturers Sends Letter to Healthcare Professionals Natalizumab Manufacturer
2010-03-31 Manufacturer Sends Safety Letter for Protopic Tacrolimus MHRA
2010-03-31 Manufacturer Updates Information on Monitoring of Rapamune (Sirolimus) Drug Levels Sirolimus MHRA
2010-03-30 Timoptol 0.5% Ophthalmic Solution Recalled at the Pharmacy Level Timolol MHRA
2010-03-30 Recall of Several Batches of Clopidogrel 75 mg Tablets Clopidogrel MHRA