GovWire

MDR number

MDR 261-05/21

Company name

hameln pharma ltd

Product name

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

Active Pharmaceutical Ingredients: amiodarone hydrochloride

Brief description of the 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 for 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 for 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.

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.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

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