Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (100 mg/2 ml vial) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that medac GmbH (t/a medac Pharma LLP) is recalling further batches of Sodiofolin 50 mg/ml solution for injection/infusion (100 mg/2 ml vial) (folinic acid) (batch number: D210211C, D210211D, D210211F, D210211G, D210211H) due to particles detected during long-term stability tests. These batches are being recalled as a precautionary measure and the root cause analysis investigation remains ongoing.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50-mg-slash-ml-solution-for-injection-slash-infusion-100mg-slash-2ml-vial-el-23-a-slash-28
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by MHRA, and was posted on the Drug Office website on 21 Jul 2023.
Ends/Tuesday, Aug 22, 2023
Issued at HKT 14:00
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