Letters and medicine recalls sent to healthcare professionals in August 2021

A summary of recent letters, medicine recalls and notifications sent to healthcare professionals

• From: Medicines and Healthcare products Regulatory Agency
• Published: 15 September 2021

• Therapeutic area: Cardiovascular disease and lipidology, Endocrinology, diabetology and metabolism, Haematology, Immunology and vaccination and Neurology

Letters

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

• Clexane (enoxaparin sodium) device – Important Information regarding differences between PREVENTIS and ERIS needle guard safety systems
• Amiodarone hydrochloride 50 mg/ml concentrate for solution for injection/infusion - potential for crystallisation
• Hizentra Syringe 20% 5ml/10ml (PLGB 15036-0156): interim supply of US Stock to mitigate supply disruption
• Fluenz Tetra nasal spray suspension, Influenza vaccine (live attenuated, nasal): supply of Great Britain-labelled stock in Northern Ireland

Medicine Recalls and Notifications

In August 2021, recalls and notifications for medicines were issued on:

Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19. Issued 5 August 2021. Batches of the following medicines are being recalled by multiple manufacturers and distributors: Aprovel 75mg, 150mg and 300mg film-coated tablets, Co-Aprovel 150mg/12.5mg, 300mg/12.5mg Film-Coated Tablets and Irbesartan Zentiva 75mg film-coated tablets. This is a precautionary recall as batches have been identified to contain an impurity of mutagenic potential that is above the acceptable limit. Stop supplying the batches immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should advise patients not to stop taking their medicine without consulting their doctor or pharmacist. The MHRA will provide further updates as our investigation progresses.

Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, EL (21)A/20. Issued 25 August 2021. A batch of Metformin hydrochloride 500mg/5ml oral solution is being recalled as the manufacturer has identified levels of N-nitrosodimethylamine (NDMA) above acceptable limits. As NDMA has genotoxic and carcinogenic potential, this is a precautionary recall. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier. Healthcare professionals should inform patients not to stop treatment without consulting their doctor, as the risk of suddenly stopping this type II diabetes medication is higher than the potential risk associated with the NDMA impurity.

Article citation: Drug Safety Update volume 15, issue 2: September 2021: 3.

Published 15 September 2021