Letters and medicine recalls sent to healthcare professionals in May 2021
A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
Letters
In May 2021, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
For all of the latest safety notices from the MHRA, see Alerts and recalls for drugs and medical devices, including a National Patient Safety Alert and Class 1 patient-level recall for a batch of Zentiva co-codamol 30/500 effervescent tablets (issued 16 June 2021).
In May 2021, recalls and Notifications for medicines were issued on:
Class 4 Medicines Defect Information, Syonell 250mg Gastro-Resistant Tablets,(PL 35507/0191), Syonell 500mg Gastro-Resistant Tablets, (PL 35507/0192), EL (21)A/11. Issued 04 May 2021. The outer packaging of several batches of Syonell (valproate semisodium) 250mg and 500mg Gastro-resistant tablets were printed with an incorrect amount of the active ingredient valproate semisodium. There is no risk to product quality as a result of this issue, however, healthcare professionals are advised to exercise caution when dispensing the product.
Class 2 Medicines Recall: AstraZeneca UK Limited, Bricanyl Injection, 0.5 mg/ml solution for injection or infusion (PL 17901/0112), EL (21)A/12. Issued 17 May 2021. A batch of Bricanyl (terbutaline sulfate) 0.5mg/ml solution for injection or infusion is being recalled as a precautionary measure due to irregular results for impurities identified during stability testing. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Company led medicines recall: LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005). Issued 19 May 2021. A batch of LysaKare 25g/25g solution for infusion is being recalled due to the identification of leakages in a small number of bags. Quarantine all remaining stock and return to supplier once the manufacturer has supplied replacement products.
Class 3 Medicines Recall: Advanz Pharma, Carbimazole 10mg and 15mg tablets, EL (21)A/13. Issued 20 May 2021. Batches of Carbimazole 10mg and 15mg tablets are being recalled as a precautionary measure due to irregularities in the tablet appearance as a result of oxidation of the excipient red iron oxide on the tablet surface. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Medical Device Safety Information
Recent MHRA Device Safety Information pages have been published on:
There was also a recent manufacturer’s notice on:
For all of the latest safety notices from the MHRA on drugs and medical devices,see Alerts and recalls for drugs and medical devices.
Yellow Card Biobank GP Survey
Finally, if you work in a GP setting, please complete this 5 to 10-minute survey to tell us your views on a new MHRA initiative to establish a Yellow Card Biobank for researchers to investigate genetic factors behind adverse drug reactions and optimise the safe use of medicines and vaccines.
Article citation: Drug Safety Update volume 14, issue 11: June 2021: 4.