The Medicines and Healthcare products Regulatory Agency (MHRA) is contacting certain individual patients to make them aware that they might have been dispensed a fake Mounjaro (tirzepatide) KwikPen 15mg solution for injection from a pharmacy in Birmingham.
The MHRA said the affected fake pens identified to date are 15mg pens with the batch number: D873576 dispensed by The Private Pharmacy Clinic in Birmingham.
The regulator said this is a legitimate batch number for genuine Mounjaro KwikPen 7.5mg, and pens at this strength are not impacted.
The General Pharmaceutical Council have served a ‘notice of conditions’ on the pharmacy involved.
MHRA chief safety officer Dr Alison Cave said, “Check the batch number and strength of your KwikPen. If you have one of the affected pens, stop using it straight away. Please report it to the MHRA by emailing info@mhra.gov.uk. Please include “Mounjaro Pens” in the subject line. Keep the pen in a safe place.
“If you have administered injections using the pen already, please be reassured that, based on the cases reviewed to date, the risk to you is low. Testing has confirmed that the identified fake pens do contain tirzepatide, the active substance in Mounjaro, but because the manufacturing conditions are unknown, we cannot confirm that the contents are sterile."
If the contents are not sterile, there is potential for infection.
The possible signs include redness, swelling or warmth around the site of the injection; pain or discomfort around the site of injection; fluid leakage from the site of injection; and mild fever, chills, fatigue, and sore throat.
The MHRA has not received any reports of patients requiring treatment after taking these fake medicines.
The issue was identified due to faults with the pens and the MHRA has notified Eli Lilly, the manufacturer of the genuine product.
