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.
