Medicines Healthcare Products Regulatory Agency
National Patient Safety Alert and recall of Targocid 200mg powder for solution for injection/infusion or oral solution
On 21 October 2022, we issued a National Patient Safety Alert to support the recall of 2 batches of the antibiotic Targocid (teicoplanin) 200mg powder for solution for injection/infusion or oral solution (batches 0J25D1 and 0J25D2; expiry 30/04/2023). This is due to out of specification results obtained for bacterial endotoxins, which has been confirmed through testing of retained samples.
This issue was observed following a medical adverse event, which reported that 4 patients experienced high grade of fever approximately 3 hours post-administration of vials from the impacted batches. Due to the out of specification results observed, there is a potential life threatening or serious risk to patient health.
Follow the advice in the National Patient Safety Alert and Class 1 Medicines Recall to stop use of these batches immediately and return to the manufacturer.
In the event the affected batches have been administered to patients, appropriate clinical assessment should be performed, in addition to close monitoring for any adverse reaction.
Although most use is in hospitals, it may have been prescribed to take at home. Identify any potential patients who may be taking it at home and ensure they stop use. GPs and other prescribers are asked to ensure that a new prescription is available for the patient when they return their medicine to the pharmacy.
All suspected adverse events should also be reported via the MHRAs Yellow Card scheme immediately.
For more information, please see the National Patient Safety Alert page.
Letters
In September 2022, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In September 2022, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Limited, Bezalip Mono 400mg Tablets, EL (22)A/38. Issued 12 September 2022. Batches of Bezalip Mono (bezafibrate) 400mg tablets have been identified to contain Patient Information Leaflets (PIL) omitting safety information on possible side effects of Stevens Johnson syndrome and toxic epidermal necrolysis. Healthcare professionals are advised to discuss the missing information with patients and provide a copy of the updated PIL, where possible.
Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Ltd, Atorvastatin 4mg/ml Oral Suspension & Sildenafil 10mg/ml Oral Suspension, EL (22)A/39. Issued 13 September 2022. Batches of Atorvastatin 4mg/ml Oral Suspension and Sildenafil 10mg/ml Oral Suspension have been identified with incorrect expiry dates stamped on the base of the bottle. The correct expiry dates (as stated in the table) are printed on the bottle label and on the outer carton. Healthcare professionals should follow the expiry date printed on the bottle label and the outer carton, and advise patients of the issue when dispensing these products.
Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40. Issued 20 September 2022. A batch of Sandimmun (ciclosporin) Oral Solution is being recalled as a precautionary measure due to ciclosporin crystals in the solution. Stop supplying the batch immediately, quarantine all remaining stock and return to supplier.
Medical Device Safety Information
In September 2022, a MHRA Device Safety Information page was published on:
Haemodialysis and haemofiltration machines: Actions to take following pressure-related alarms to avoid unintentional alteration of alarm limits DSI/2022/004. Issued 21 September 2022. Venous and arterial pressure limits may be altered unintentionally following acknowledgement of the alarm in some haemodialysis and haemofiltration machines. The MHRA is aware of serious events, including some with a fatal outcome, where following an alarm the lower pressure limits suggested by the machine were too low. If the underlying cause of the alarm is not addressed, the machine may not re-alarm to alert the user to an ongoing problem. Actions and advice for heads of renal units and renal nursing staff are available in the device safety information page.
For all of the latest safety notices from the MHRA on drugs and medical devices, see Alerts and recalls for drugs and medical devices.
Consultation on how MHRA communicates with healthcare professionals
The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. The MHRA has launched a consultation to enable healthcare professionals across the UK to have their say on how they wish to receive vital safety information, how theyd like to be engaged, and to feedback on the Yellow Card safety reporting system.The consultation will close at 11:45pm on 18 January 2023. Please see the consultation page for more information.
Article citation: Drug Safety Update volume 16, issue 3: October 2022: 3.