Sanofi has issued an urgent recall notice for two contaminated batches of Targocid 200mg powder for solution for injection/infusion or oral solution, the MHRA has said.

Bacterial endotoxins were found following a medical adverse event, where four patients experienced high grade of fever approximately three hours after vials from the impacted batches were administered.

The MRHA said that the contamination could cause a life threatening or serious risk to patient health.

It said that by 26 October 2022, pharmacists must:

  1. Stop supplying batch numbers 0J25D1 or 0J25D2, quarantine all remaining stock and return it to the supplier.
  2. Immediately identify whether any affected batches have been administered to patients, and put an action plan in place to ensure appropriate clinical assessment and monitoring.
  3. Put an action plan in place to identify whether your organisation has supplied any affected batches to patients to use at home. If batch traceability information is not available, identify any patients dispensed this product since 28 July 2022. Request patients to return any impacted batches for disposal.
  4. Contact all patients who may be using the impacted batches, and if they have any impacted product help them source alternative supplies, including counselling affected patients to contact their General Practitioners (GPs) or other relevant prescribers to arrange a new prescription.

It said that the response should be coordinated by the chief pharmacist/superintendent pharmacist/responsible pharmacist and dispensing GPs in the first instance.

It has advised healthcare professionals, including pharmacists, to be aware of the following clinical symptoms and report any suspected adverse effects via the MHRA’s Yellow Card scheme:

  • A high temperature (fever) 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 – such as confusion or disorientation
  • Loss of consciousness
  • Slurred speech
  • Nausea and vomiting and/or diarrhoea

Read the full Patient Safety Alert on the MHRA website.