Letters and drug alerts sent to healthcare professionals in March 2020

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

Letters

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

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

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.

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The Emerade recall is no longer active.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.

Updates to this page

Published 27 April 2020