Letters and drug alerts sent to healthcare professionals in October 2020

A summary of letters and drug alerts recently sent to healthcare professionals.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 16 November 2020

• Therapeutic area: Cancer, Endocrinology, diabetology and metabolism, Haematology, Infectious disease, Paediatrics and neonatology, Respiratory disease and allergy and Urology and nephrology

Letters

In October 2020, the following letters were sent or provided to relevant healthcare professionals:

• Esbriet (pirfenidone): important safety update and new recommendations to prevent drug-induced liver injury (DILI)

• Monofer 100mg/ml solution for injection/infusion▼ and Diafer 50mg/ml solution for injection▼: name change from iron isomaltoside to ferric derisomaltose

• Harvoni 45 mg/200 mg film-coated tablets (ledipasvir/sofosbuvir): supply of Irish product

• MUSE urethral sticks (alprostadil): Supply of packs with known anti-tamper seal issue

• Envarsus 1mg modified release oral tablets (tacrolimus): Interim Supply to Mitigate Supply Disruption

• Nytol Liquid Caramel Flavour 10mg/5ml oral solution Diphenhydramine Hydrochloride: removal of the allergy indication; should only be sold as an adult sleep aid*

• ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion (Irinotecan): interim supply of Irish stock to mitigate supply disruption*

• Semglee▼ 100 units/ml x 3ml prefilled pens (Insulin glargine): interim supply of Portuguese stock to mitigate supply disruption*

*These letters were included in October 2020 Drug Safety Update but are included in this list since they were issued in October 2020.

Drug alerts

Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47. Issued 6 October 2020. A specific batch of Hydrocortisone 1% w/w Ointment is being recalled as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa. Stop supplying the batch immediately and return to supplier. Patients are advised to speak to their doctor or pharmacist if they experience any worsening of symptoms or other side-effects.

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.

Class 3 Medicines Recall: Metoprolol 50 mg Tablets (PL 20075/0304), EL (20)A/49. Issued 14 October 2020. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’ Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032). Issued 22 October 2020. Certain batches of these products are being recalled as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of the pre-filled syringe and tubing catheter. In some cases this has resulted in leakages of contrast media during use.

Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD 0.25 microgram capsules (PL 49876/0001), EL (20) A/50. Issued 29 October 2020. Upon decommissioning at the pharmacy and when scanning the serialised 2D code, the status of packs may report as ‘EXPORT’. This is a second alert for further batches identified. Although there is no risk to product quality, any remaining stock should be quarantined and returned.

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Article citation: Drug Safety Update volume 14, issue 4: November 2020: 6.

Published 16 November 2020