Chemist + Druggist is part of Informa PLC


This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.


This copy is for your personal, non-commercial use. Please do not redistribute without permission.

Printed By

UsernamePublicRestriction

MHRA to pharmacies: Stop supplying specific batch of metformin oral solution

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked pharmacies to “immediately” stop the supply of a specific batch of metformin oral solution, after a nitrosamine impurity was identified.

Pharmacies should “quarantine all remaining stock and return it to your supplier”, the MHRA advised yesterday (August 26) of the affected batch of Rosemont Pharmaceuticals Limited’s metformin hydrochloride 500mg/5ml oral solution.

While “very low levels” of nitrosamines have been identified in the batch, these can become harmful if consumed over a long period of time, the medicines watchdog said.

“To date, there is no evidence that this impurity has caused any harm to patients,” the MHRA stressed, and the wholesaler and pharmacy recall is just a “precautionary [measure] to prevent further exposure”.

 

Patients shouldn’t stop taking their medicine

 

Despite the recall, patients are advised to continue taking their medication and should consult their “healthcare team” as “the risks of suddenly stopping medication for type 2 diabetes is higher than the potential risk presented by the impurity”, the MHRA stressed.

Details of the affected batch are:

Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139

Batch number  
0LL0018 
Expiry date
Nov 2021  
Pack size 
150ml  
First distributed
December 2020

Related Content

Topics



Pharmacy Dispenser/ Technician
Bethnal Green North, London
Salary: Up to £30,000

Apply Now
UsernamePublicRestriction

Register

CD135402

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel