MHRA Class 2 Medicines Recall: Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion

Drug alert number: EL(22)A/42

Date issued: 10 October 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion – Hameln pharma ltd – PL 25215/0026

Batch Number Expiry Date Pack Size First Distributed
210505 03/2024 10 x 3 ml 04/08/2022

Active Pharmaceutical Ingredients: amiodarone hydrochloride

Brief description of the problem

Hameln pharma ltd is initiating a recall of batch 210505 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 are not 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 on the 24th 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.

Full drug alert can be viewed here.

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.

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