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| The United Kingdom: Class 2 Medicines Recall: hameln pharma ltd, Ephedrine Hydrochloride 30 mg/ml Solution for Injection (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection (batch number: 11081120C, 04600520C) as a precautionary measure. This is due to out of specification results obtained during routine ongoing stability studies, for related substances. Due to the out of specification results observed at higher storage temperatures, ampoules from the affected batches may no longer be in line with the licensed product specification.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-ephedrine-hydrochloride-30-mg-slash-ml-solution-for-injection-el-22-a-slash-44
In Hong Kong, Ephedrine-hameln Solution for Injection 30mg/1mL (HK-66845) is a pharmaceutical product registered by Mekim Ltd. The product is a prescription-only medicine. As confirmed by Mekim Ltd, the affected batches have not been imported into Hong Kong.
Ends/Friday, Oct 21, 2022
Issued at HKT 14:00
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