Medicines Healthcare Products Regulatory Agency
Letters
In May 2023, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In May 2023, recalls and notifications for medicines were issued on:
Class 3 Medicines Recall: Hikma Farmacutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial, EL(23)A/16. Issued 10 May 2023. Hikma Farmacutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification. Due to a limited number of complaints received regarding loose caps, Hikma Farmacutica Portugal S.A is recalling the batches as a precautionary measure from pharmacies and wholesalers. Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.
Class 4 Medicines Defect Information: Novartis Pharmaceuticals, Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion, EL (23)A/17. Issued 16 May 2023. Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection may contain glass fragments approximately 20 800 m in size. Therefore, the included solvent should not be used, but replaced with an alternative water for injection. The quality of the Simulect vials themselves is not affected and due to supply considerations, the impacted batches are not being recalled.
Class 4 Medicines Defect Information: Orifarm UK Ltd, Buccolam 10mg Oromucosal solution, EL (23)A/18. Issued 22 May 2023. Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use. All other sections of the PIL are unaffected. The information in step 1 of the PIL should include text indicating to break the seal at one end. Healthcare professionals are advised to inform patients of the error in the PIL. The Marketing Authorisation Holder can supply copies of the correct PIL on request, so that any affected packs remaining in the dispensary can be supplemented with the correct information. Future copies of the PIL will reflect the correct information.
Class 4 Medicines Defect Information: Drugsrus Limited / Dawa Limited, Metronidazole 200 mg/5 ml Oral Suspension, EL (23)A/19. Issued 23 May 2023. Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking. The probable cause of this defect relates to the possibility of a slight defect in the cap or bottle threads. Only the batches listed in this notification are affected. Due to the very low number of complaints received and the high visibility of the defect usually prior to dispensing, the product is not currently being recalled. Healthcare professionals are advised to check any incoming bottles from the batches listed. Do not dispense any bottles that are leaking. Quarantine any affected bottles immediately. Contact Drugsrus Limited for replacement and further advice. Patients who have a bottle of Metronidazole 200 mg/5 ml Oral Suspension 100ml that is leaking should contact their pharmacy team to arrange a replacement.
National Patient Safety Alert on removal of Philips Health Systems V60 and V60 Plus ventilators from service
On 18 May 2023, we issued a National Patient Safety Alert to instruct that all Philips V60 and V60 Plus ventilators should be permanently removed from use in the UK healthcare system by no later than 30 September 2023. This is due to electrical issues with the devices that may, in rare instances, cause them to shut down unexpectedly.
If there is a risk of severe patient harm due to a lack of alternative ventilators, providers may continue to use affected ventilators until 30 September 2023, but only with appropriate risk mitigation measures in place see Risk assessment and additional patient monitoring requirements if temporary use of affected devices cannot be avoided. However, all V60 range ventilators must be removed from service with replacement devices in use by 30 September 2023.
We are working closely with the Department of Health and Social Care, who will be able to provide information on arrangements to supply replacement ventilators to any hospitals where staff feel they are needed, to ensure capacity is maintained.
Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors, due to the potential for device failure
On 9 May 2023 we issued a National Patient Safety Alert with detailed instructions to support the recall from patients of all unexpired Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens). This is due to an issue identified during testing where some auto-injectors failed to deliver the product or activated prematurely after they had been dropped.
It is unclear what impact this has on auto-injectors in clinical use, however as a precautionary measure and owing to the inability to identify this issue before the auto-injectors are used, all Emerade auto-injectors are being recalled in the UK.
General Practitioners (GPs) and Pharmacy Teams are asked to send the linked letter Advice for patients who have been prescribed Emerade auto-injectors to all patients and carers who have been prescribed Emerade auto-injectors. For further information on safe and effective use of adrenaline auto-injectors please refer to the MHRAs Adrenaline Auto-Injectors (AAIs) safety campaign.
Article citation: Drug Safety Update volume 16, issue 11: June 2023: 4.