A number of Mounjaro pens supplied by an online pharmacy have been issued a safety alert (Image: Getty)
A safety alert has been issued for anyone using Mounjaro after a falesified version of the medication was supplied to the public. Certain batches of the pen, which is an injectable prescription medicine approved for weight management, have been recalled, issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
An online pharmacy was found to be providing a version that failed to meet safety standards to consumers. The safety alert was issued on Tuesday, February 24, and applies to the solution for injection in pre-filled pen only. The Mounjaro KwikPen 7.5mg pens with this batch code are not affected. Five of the affected pens have been identified as being supplied through the Private Pharmacy Clinic in Birmingham.
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The Mounjaro product affected by this alert include:
- Mounjaro (tirzepatide) KwikPen 15mg – batch D873576
Tests of the medications confirmed that they do contain tirzepatide, however, their manufacturing process is unknown, therefore “sterility cannot be guaranteed”. As the product is injectable and its content are not sterile, there is a potential risk of infection and allergic reactions.
Possible signs of infection can 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.
Symptoms of an allergic reaction may include a rash, itching or difficulty breathing. Patients who experience any symptoms of infection or an allergic reaction are being advised to seek medical help immediately.
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The affected Mounjaro (tirzepatide) KwikPen 15mg has the batchcode D873576 (Image: Which?)
The MHRA explained that it has not received any reports of patients requiring treatment after taking these fake medicines. The issue was identified due to faults with the pens, where in all but one case the dose knob came off while in use.
The MHRA was notified of these counterfeits by the manufacturer of the genuine product, Eli Lilly and Company Limited, which has received five reports of faulty pens.
Dr Alison Cave, Chief Safety Officer at the MHRA 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 you are unsure of how to identify the pen, or are unsure on whether you have administered an affected product and have any questions, please speak to a healthcare professional.”
Any patients or consumers who suspect they’ve received a counterfeit medicine or has noticed any fault with a weight-loss pen should report it directly to the Yellow Card scheme, either through the website www.yellowcard.mhra.gov.uk . The scheme can also be found via Google Play or Apple App stores.
