Letters and medicine recalls sent to healthcare professionals in March 2021

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 27 April 2021

• Therapeutic area: Anaesthesia and intensive care, Cancer, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Infectious disease, Neurology, Nutrition and dietetics, Paediatrics and neonatology, Pain management and palliation, Psychiatry, Radiology and imaging, Respiratory disease and allergy

Letters

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

• Zolgensma▼ (onasemnogene abeparvovec): Risk for thrombotic microangiopathy

• Xeljanz▼ (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF-alpha inhibitors

• Tecentriq (atezolizumab): risk of severe cutaneous adverse reactions (SCARs)

• Sublimaze Solution for injection, 50μg/ml (Fentanyl citrate): Interim Supply of Ireland Stock to Mitigate Supply Disruption

• Finomel Emulsion for Infusion (1435ml - 1101320): Interim Supply of Belgian Stock to Mitigate Supply Disruption

• Cholediam, kit for the preparation of technetium [99mTc] mebrofenin injection (Mebrofenin): Interim Supply of French Stock to Mitigate Supply Disruption

We are also aware of the following letter, sent to relevant healthcare professionals in February 2021:

• Lojuxta (lomitapide): Reminder to monitor the liver function of patients and to avoid use in pregnancy

Medicines Recalls and Notifications

Class 3 Medicines Recall: Easyhaler Salbutamol Sulfate 100 micrograms per actuation/200 micrograms per actuation inhalation powder, EL (21)A/06. Issued 1 March 2021. Defects have been identified in two batches of Easyhaler Salbutamol Sulfate 100 micrograms and 200 micrograms per actuation inhalation powder. A hole in the bulk chamber where inhalation powder is stored has potential for a minor loss of inhalation powder. As a precautionary measure, the product is being recalled. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information, Accord Diazepam 2mg/5ml Oral Solution Sugar Free (EL (21)A/07) (PL 0142/0103). Issued 9 March 2021. Batches of Accord’s Diazepam 2mg/5ml oral solution have been identified with incomplete product information. The products have outdated sorbitol wording and are missing important excipient safety wording on propylene glycol. Accord will provide hard copies of updated leaflets to pharmacies. When prescribing, healthcare professionals are asked to inform patients and provide updated product leaflets from the supplier when dispensing the product.

Class 3 Medicines Recall: Thame Laboratories, Itraconazole 10mg/ml Oral Solution, EL (21)A/08. Issued 15 March 2021. Two batches of Itraconazole 10mg/ml oral solution are being recalled due to defective child-resistant container closures which are difficult to open. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.

Class 4 Medicines Defect Information, Caffeine Citrate 10mg/ml Solution for Injection, (PL 01883/0344), EL (21)A/09. Issued 18 March 2021. A batch of Caffeine Citrate 10mg/ml Solution for Injection has been identified with an incorrect EAN barcode on the outer carton. Scanning the barcode will show the batch as Methylthionium Chloride Injection 1%. There is no risk to product quality, and all other packaging components are correct. Healthcare professionals are advised not to use barcode scanning for any activities related to this batch and to use caution when supplying or dispensing this item, as the barcode may show incorrectly on automated pharmacy inventory systems.

Article citation: Drug Safety Update volume 14, issue 9: April 2021: 3.

Published 27 April 2021