MHRA Class 2 Medicines Recall: Ephedrine Hydrochloride 30 mg/ml Solution for Injection

Drug alert number: EL(22)A/44

Date issued: 20 October 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: Ephedrine Hydrochloride 30 mg/ml Solution for Injection – hameln pharma ltd PL 01502/0103

Batch Number Expiry Date Pack Size First Distributed
11081120C 11/ 2023 10 x 1 ml 14/06/2021
04600520C 05/ 2023 10 x 1 ml 30/09/2020

Active Pharmaceutical Ingredients: ephedrine hydrochloride

Brief description of the problem

hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection 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.

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.

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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