Letters and drug alerts sent to healthcare professionals in March 2020

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 27 April 2020

• Therapeutic area: Anaesthesia and intensive care, Immunosuppression and transplantation, Infectious disease, Neurology, Obstetrics, gynaecology and fertility, Pain management and palliation, Psychiatry, Respiratory disease and allergy

Letters

In March 2020, the following letters were sent to relevant healthcare professionals:

• Esmya 5mg (ulipristal acetate) for uterine fibroids: not to be used during ongoing review of liver injury risk – see Drug Safety Update, March 2020 and Class 2 recall notice

• Adoport (tacrolimus) 2mg capsules: limited number of packs with Italian foil

• Fennings Paracetamol 120mg/5 ml Oral Suspension (Crescent Pharma Ltd): 200ml pack size on a GSL authorisation; only to be supplied under the supervision of a pharmacist

• Ativan 4mg/ml Solution for Injection (Lorazepam): interim supply of Irish stock to mitigate supply disruption

• Zentiva Paracetamol 500mg Capsules (pack size 100 capsules) supplied with incorrect information in Patient Information Leaflet

We are also aware of the following key letters sent to healthcare professionals so far in April 2020:

• Noradrenaline (Norepinephrine) 4mg/4ml concentrate for solution for infusion: temporary supply of a different presentation in market and changes to the instructions

• Suxamethonium: temporary foreign label product - Label and patient information leaflet (PIL) is in Portuguese

Recall of Emerade adrenaline auto-injectors

Pharmaswiss Česka republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) has recalled all unexpired batches of Emerade 150 microgram and 300 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.

• Class 2 Medicines Recall: Emerade 150 micrograms solution for injection in pre-filled syringe, PL 33616/0013 (EL(20)A/14). Issued 3 March 2020

• Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20). Issued 7 April 2020

Post-publication note: December 2021.

The Emerade recall is no longer active. Following an MHRA investigation and corrective action by the manufacturer, in November 2021 the MHRA approved Emerade 300 microgram and 500 microgram auto-injectors to be resupplied to the market. Please see Drug Safety Update November 2021 for more information.

Other recalls and notices issued in March 2020

Class 2 Medicines Recall: AOP Orphan Pharmaceuticals AG, Tetrabenazine 25 mg tablets, PL 21344/0015, (EL (20)A/13). Issued 2 March 2020. AOP Orphan Pharmaceuticals AG is recalling all unexpired stock of batch T1704UK of Tetrabenazine 25mg tablets (from pharmacies and wholesalers) as a precautionary measure due to out of specification results obtained during routine stability testing.

Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Paracetamol 250mg/5ml Oral Suspension (500ml) PL 00427/0078 EL (20)A/19. Issued 30 March 2020. There is an error in the barcode and GTIN number of the label on the bottle of the listed batches. When identifying the product strength, use the labelled contents’ not the strength stated when the barcode is scanned or the GTIN number on the dm&d browser website.

Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules, PL 46302/0149 (EL (20)A/18). Issued 24 March 2018. Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the listed batches is incorrect. The GTIN barcode should not be used for any dispensing activities for the affected batches.

Class 4 FMD Medicines Information: WDA(H) 50340 HMS Wholesale Limited, Multiple Products, (EL (20)A/17). Issued 19 March 2020. The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via WDA(H) 50340 HMS Wholesale Limited. Check stocks for the listed products. If any relevant packs are identified, quarantine and notify the MHRA.

Class 4 Medicines Defect Information: Aripiprazole 1mg/ml Oral Solution, PL 04569/1667, (EL(20)A/15). Issued 11 March 2020. Mylan UK Healthcare Ltd has informed us that a product complaint has been received relating to crystalline precipitate being observed during bottle use. Inspect the product before administration and only use if clear and free from crystalline precipitate.

Drug Safety Update volume 13, issue 9: April 2020: 2.

Published 27 April 2020