Class 2

Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL(22)A/31

hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.

MDR Number: MDR 261-05/21

Company name: hameln pharma ltd

Product description: Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion PL 25215/0026

Details of the affected batch:

Batch number

Expiry date

Pack size

First Distributed

207506

02/2024

10 x 3ml

14/04/2022

Active Pharmaceutical Ingredients: amiodarone hydrochloride

Brief description of problem: hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure. This is due to an increased presence of visible crystalline particles within the solution, identified during ongoing re-inspection of retained samples.

Advice to Healthcare Professionals: Please quarantine any remaining stock of this batch and contact hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk to arrange credit for any unused ampoules from this batch. Replacement batches of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion (product code: AMIOD) are available from hameln pharma ltd.

The potential for amiodarone solutions for injection/infusion to crystallise and the associated potential for amiodarone-induced phlebitis are known and have been discussed in a Direct Healthcare Professional Communication (DHPC) previously published 24 August 2021.

For all remaining batches Healthcare professionals are advised to visually inspect ampoules of amiodarone for clarity, particulate matter, discolouration and the integrity of the container; Only use the solution if it is clear, free from particles and the container is undamaged and intact.

Advice to Patients: Patients are not required to take any action at this time. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Company contacts for further information: For more information or supply queries, please contact or email hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk.

For medical information queries, please contact or email hameln pharma ltd Medicines Information on +44 (0)1452 621 661 or drug.safety@hameln-pharma.co.uk.

To access the full recall: Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion, EL(22)A/31