Urgent Safety Warning Issued for Mounjaro Users After Counterfeit Pens Discovered
A critical safety alert has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) following the discovery of falsified Mounjaro pens being distributed to the public. The regulatory body is urging anyone using this injectable prescription medication for weight management to check their batch numbers without delay.
Specific Batches Recalled After Online Pharmacy Supply
The alert, released on Tuesday, February 24, relates specifically to the solution for injection in pre-filled pens. An online pharmacy was found to be supplying a version that did not meet established safety standards. Investigations have identified that five affected pens were distributed through the Private Pharmacy Clinic in Birmingham.
The affected product is the Mounjaro (tirzepatide) KwikPen 15mg with batch code D873576. It is important to note that the Mounjaro KwikPen 7.5mg pens are not impacted by this recall.
Significant Health Risks Identified
Laboratory testing confirmed that the counterfeit pens do contain the active substance tirzepatide. However, because the manufacturing conditions are completely unknown, sterility cannot be guaranteed. This presents a serious potential risk of infection and allergic reactions for users.
Potential signs of infection include:
- Redness, swelling, or warmth around the injection site
- Pain or discomfort at the site
- Fluid leakage from the injection point
- Mild fever, chills, fatigue, and sore throat
Signs of an allergic reaction may involve:
- Development of a rash
- Itching sensations
- Breathing difficulties
Anyone experiencing these symptoms should seek urgent medical attention immediately.
MHRA Investigation and Official Guidance
The MHRA was alerted to the counterfeit products by the genuine manufacturer, Eli Lilly and Company Limited, which had logged five reports of faulty pens. The issue came to light primarily through defects with the pens, where the dose knob was detaching during use in all but one instance.
Dr Alison Cave, Chief Safety Officer at the MHRA, provided clear instructions: "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 with 'Mounjaro Pens' in the subject line. Keep the pen in a safe place."
She added reassurance for those who may have already used an affected pen: "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, but because the manufacturing conditions are unknown, we cannot confirm that the contents are sterile."
Reporting Suspected Counterfeit Medications
The MHRA confirmed that it has not received any reports of patients requiring treatment following use of these counterfeit medications. However, vigilance remains paramount.
Anyone who suspects they have been given a counterfeit medication or has noticed any defect with a weight-loss pen should report it directly to the Yellow Card scheme. This can be done via the official website at www.yellowcard.mhra.gov.uk or through the dedicated mobile applications available on both Google Play and the Apple App Store.
Patients who are unsure about identifying their pen or whether they have administered an affected product are strongly advised to consult a healthcare professional for guidance and clarification.
