Class 4 Caution in Use
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.
MHRA drug alert date: 18th January 2024
MHRA drug alert link: https://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?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0b5575da-3811-4212-b5f0-7d8d33ce231e&utm_content=immediately
Pip code | Product | Supplier | Affected Batches |
8062242 | SUGAMMADEX SOD INJ 100MG/1ML | NOVUMGEN LTD GENERICS | 35000347 |
1266741 | SUGAMMADEX INJ 100MG/ML TEV | TEVA UK LTD | 35000347 |
This is a caution in use only we are not accepting stock returns
Further Information
For medical information enquiries please contact medical info at USV on medicalinfo@usvuk.com or phone: 00 800 89013370
For stock control enquiries please contact Novumgen on tapan.parmar@novumgen.uk or phone: 0203 096 6496 on extension 5 (Please note Novumgen is the first-line distributor of USV UK products in the UK).