Other safety alerts
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| The United Kingdom: Class 4 Medicines Defect Information: USV UK Limited, Sugammadex 100 mg/ml solution for injection (2 ml vial) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial) (batch number: 35000347) may contain some vials that contain a low volume of solution (less than the label claim of 2 ml).
USV UK Limited has received a single market complaint of a vial containing 1.6 ml of product, which has been confirmed with additional testing. This notification is a precautionary measure to inform healthcare professionals of the potential for some vials in the specific batch to be of lower volume. Due to considerations related to product supply, this batch is not being recalled.
Healthcare professionals are advised to check stock levels of Sugammadex 100 mg/ml solution for injection (2 ml vial) with batch number of 35000347 and consider that additional vials may need to be used to supplement the required dosage in line with the requirement of individual patient treatment.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-usv-uk-limited-sugammadex-100-mg-slash-ml-solution-for-injection-2-ml-vial-el-24-a-slash-02
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jan 19, 2024
Issued at HKT 15:00
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