Sanofi UK has urgently recalled batches of the antibiotic powder teicoplanin (Targocid) after tests revealed the presence of bacterial endotoxins.
Four patients had experienced high-grade fever three hours after administration of vials from the affected batches, the class 1 recall notification said.
It relates to two batches of 200mg teicoplanin powder to be made up for injection/infusion or oral solution that were distributed in July and August 2022.
Healthcare professionals have been asked to stop supplying the batches (0J25D1 and 0J25D2) and pharmacists involved in dispensing the product to immediately contact all patients who have been issued the potentially contaminated batches since 28 July 2022.
Patients with any impacted product left will need to return them for disposal and be given a new prescription where necessary, officials said.
Issuing details of the recall on 21 October 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) said there was a “potential life threatening or serious risk to patient health”.
Healthcare professionals have been told to look out for symptoms, including high or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhoea.
Alison Cave, chief safety officer at the MHRA, said: “We have taken prompt action to ensure affected batches will no longer be given to patients. Other products containing teicoplanin have not been affected by this recall.”
Stephen Hughes, consultant antimicrobial pharmacist at Chelsea and Westminster NHS Foundation Trust, said teicoplanin is widely used in theatres for surgical prophylaxis and for skin and soft tissue infection, but it is also used in primary care.
He added: “As it is licensed, we do not routinely collect the batch numbers so we have to overestimate the numbers of exposed patients. We called these patients who were at home and enquired to any issues. For inpatients, these are easier to observe and the medical teams are informed of the alert.”
Jamie Harris, chief pharmacist at County Durham and Darlington NHS Foundation Trust, said class 1 recalls were rare but this had been the second in 2022. However, he added that they had been given five days to implement it, whereas it used to be 24 hours.
“We still treat them that way, so spent our Friday ringing patients at home to read the batch number off their teicoplanin vials.
“The newer pharmacy robots track it via the GS1 barcode, otherwise you have to find the delivery note to check what batches you’ve got.”