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The United Kingdom: Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion
 
Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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.

Please refer to the following website in MHRA for details: http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-amiodarone-hydrochloride-50-mg-slash-ml-concentrate-for-solution-for-injection-slash-infusion-el-22-a-slash-42

In Hong Kong, Amiodarone-hameln Concentrate For Solution For Injection/Infusion 150mg/3ml (HK-65675) is a pharmaceutical product registered by Mekim Ltd. The product is a prescription-only medicine. As confirmed by Mekim Ltd, the affected batch has not been imported into Hong Kong. Related news was previously issued by MHRA, and was posted on the Drug Office website on 20 Jul 2022.

Ends/Wednesday, Oct 12, 2022
Issued at HKT 14:00
 
Related Information:
The United Kingdom: Class 2 Medicines Recall: hameln pharma ltd, Amiodarone Hydr... Posted 2022-07-20
 
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