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An online pharmacy based in Birmingham has been ordered by the GPhC not to obtain, sell or supply any prescription medicines or medical devices amid concerns it has dispensed “fake” Mounjaro pens.

The MHRA announced on Tuesday February 24 that it was contacting individual patients to advise them there is a “small possibility” they may have been dispensed fake Mounjaro KwikPen 15mg injectable devices by The Private Pharmacy Clinic.

The affected pens that have been identified to date are all 15mg pens with the batch number D873576 and were dispensed by the Birmingham pharmacy. This is a legitimate batch number for 7.5mg Mounjaro pens and pens at that strength are not impacted, the MHRA said

The regulator said it has not yet received any reports of patients requiring treatment after using the affected pens. Manufacturer Eli Lilly alerted the MHRA to the faulty pens, with testing showing that “in all but one case the dose knob came off while in use”.

MHRA chief safety officer 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 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. 

“If you suspect that you’ve had a side effect as a result of using these affected pens, or suspect it’s not a genuine product, or have a defective pen, you can report it to our MHRA Yellow Card scheme. It is important you do not try to extract any of this medicine if a pen is defective in any way. 

“If you have a 15mg pen and the batch number is different to D873576, please continue to take the medication as directed by your prescriber.” 

In its February 19 enforcement notice against The Private Pharmacy Clinic, the GPhC said the business had failed consecutive inspections and has been unable to demonstrate that restricted activities always have the oversight of a responsible pharmacist.

The GPhC added: “There are serious concerns about the pharmacy’s ability to operate safely and effectively.

“The concerns are ongoing, and patients and members of the public continue to use the services of the pharmacy.

“It is therefore necessary to impose the condition with immediate effect to protect the health, well-being and safety of patients and members of the public.”