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.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 17 June 2021

• Therapeutic area: Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Obstetrics, gynaecology and fertility, Ophthalmology and Paediatrics and neonatology
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  Pain management and palliation, Psychiatry, Respiratory disease and allergy, and Urology and nephrology

Letters

In May 2021, the following letters were sent or provided to relevant healthcare professionals:

• INOmax (nitric oxide): Difficulties in closing the cylinder valves after use if the cylinder is not empty: precautions for use when disconnecting the cylinders from pressure regulators

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:

• Recall of BD Venflon Pro safety and Venflon Pro IV cannula

There was also a recent manufacturer’s notice on:

• Recall of Certain Lots of Bausch + Lomb Contact Lens Solutions, Eye Wash and Eye Lubricants

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.

Published 17 June 2021