Safety Alerts & Recalls

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Latest Alerts

Strathclyde Pharmaceuticals Ltd recalls single batch of Xarelto 20mg film-coated tablets after reports of rogue blister strips of 15 mg tablets within packs of 20 mg tablets
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert advising the recall of one batch of Xarelto (Rivaroxaban) 20mg tablets. The affected batch number is BXHHDR1 with expiry date 09/2019, and it was first distributed on 18/09/2017. This follows reports to the manufacturers, Strathclyde Pharmaceuticals Ltd, of a rogue blister strip of 15 mg tablets being found within two packs of 20 mg tablets. As a result, they have decided to recall the entire batch. Xarelto, which contains the medication Rivaroxaban, thins the blood and is used to prevent blood clots and lower the risk of stroke. For more information and for a comprehensive list of batch numbers affected, please visit: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-xarelto-20-mg-film-coated-tablets-rivaroxaban
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Healthcare Professionals Advised of Serious Cardiac-Related Adverse Reactions with High Doses of Loperamide
The Medicines and Healthcare products Regulatory Agency (MHRA) has written to healthcare professionals following a European review showing an increase in cardiac-related adverse events connected to high doses of loperamide. The maximum recommended daily dose is 16mg, and various effects on the heart rhythm were linked to those taking 40-80mg and above. As a result of the European review, all manufacturers of loperamide products have been asked to update their product information to include warnings of cardiac events associated with high doses. The patient leaflet will also be updated to warn patients never to take more than the recommended amount. Loperamide, also known by the brand name Imodium, is used for the symptomatic treatment of acute diarrhoea. For more information, please visit: https://www.gov.uk/drug-safety-update/loperamide-imodium-reports-of-serious-cardiac-adverse-reactions-with-high-doses-of-loperamide-associated-with-abuse-or-misuse
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Date Published Title Medicine Source
2017-12-08 Strathclyde Pharmaceuticals Ltd recalls single batch of Xarelto 20mg film-coated tablets after reports of rogue blister strips of 15 mg tablets within packs of 20 mg tablets MHRA
2017-12-08 Healthcare Professionals Advised of Serious Cardiac-Related Adverse Reactions with High Doses of Loperamide Loperamide MHRA
2017-12-08 Healthcare Professionals Advised of the Contraindication of Daktarin oral gel in Patients Taking Warfarin Warfarin MHRA
2017-12-08 Healthcare Professionals Advised of the Risk of Severe Respiratory Depression with Gabapentin Gabapentin MHRA
2017-12-08 Pfizer Recalls Batches of Atorvastatin and Lipitor Due to Potential of Out of Specification Result for Microbiological Testing Atorvastatin MHRA
2017-12-08 Takeda Recalls One Batch of Calcichew-D3 caplets due to non-approved excipient being found Calcium MHRA
2017-12-08 Healthcare Professionals Advised of Dose-Dependent QT-Prolonging Effects of Quinine and Updated Medicine Interactions Quinine Sulphate MHRA
2017-12-08 Healthcare Professionals Reminded to Prescribe and Dispense Tacrolimus by Brand Name Only Tacrolimus MHRA
2016-07-06 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone 750 mg Tablets Nabumetone FDA
2016-02-03 Los Profesionales Sanitarios Informados: Viekirax (Ombitasvir, Paritaprevir, Ritonavir) No Recomendado En Pacientes Con Determinados Problemas En El Hígado AEMPS
2015-05-28 RelonChem Recalls All Unexpired Tramadol 50mg Capsules Over Fungal Contamination Risk Tramadol MHRA
2015-02-19 Healthcare Professionals Advised of New Law that Sets Blood Concentration Limits for Certain Drugs When Driving Methadone MHRA
2015-02-19 MHRA Advises Healthcare Professionals that Spiriva Respimat and Handihaler Have Similar Benefits and Risks Tiotropium MHRA
2015-02-19 Clinigen Advises Healthcare Professionals About Vibativ Safety Concerns MHRA
2015-02-19 Healthcare Professionals Advised Not to Use Erivedge in Women of Childbearing Potential MHRA
2015-02-17 MHRA Advises Lowest Effective Dose of HRT Should Be Used for Shortest Possible Time Ethinylestradiol MHRA
2014-11-12 Glaxo SmithKline Recalls Zovirax Eye Ointment Over Impurities Aciclovir MHRA
2014-09-05 Motilium No Longer Available Over the Counter Without a Prescription Domperidone MHRA
2014-07-02 Procoralan Linked to Potential Risk of Heart Attack and Stroke in Patients with Slow Heart Beat Ivabradine MHRA
2014-07-02 Healthcare Professionals Reminded of the Risks of Accidental Exposure to Fentanyl Patches Fentanyl MHRA