Letters and drug alerts sent to healthcare professionals in September 2020
A summary of letters and drug alerts recently sent to healthcare professionals.
In September 2020, the following letters were sent or provided to relevant healthcare professionals:
We are also aware of the following letters issued or provided to healthcare professionals in October 2020:
Drug alerts
Class 4 FMD Medicines Information: WDA(H) 49276 Kingsley Specials Ltd, Multiple Products, (EL (20)A/42). Issued 1 September 2020. The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that do not hold a wholesale dealers authorisation and then sold it on to a number of other wholesalers. Follow advice in the alert for identifying affected products.
Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets. Issued 7 September 2020. A specific batch of Amlodipine 10mg tablets is being recalled as a precautionary measure due to out of specification results obtained during stability testing. Stop supplying the batch immediately and return to supplier.
Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44. Issued 10 September 2020. The Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm products is missing important safety information related to potential suicide risks. If dispensing, make patients aware of missing information from the PIL provided in their packs.
Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45. Issued 16 September 2020. Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown. Follow the advice in the alert for return of affected batches.
Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD Capsules, EL (20) A/46. Issued 29 September 2020. When decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs of AlfaD capsules may report as ‘EXPORT’. Although there is no risk to product quality, any remaining stock should be quarantined and returned.
Healthcare professionals should also be aware of the following alert, issued October 2020: Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48. Issued 14 October 2020. Batches of this valproate medicine are being recalled as a precautionary measure due to out of specification results during routine stability testing. Stop supplying the batch immediately and return to supplier.
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Article citation: Drug Safety Update volume 14, issue 3: October 2020: 7.