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CLASS 2 RECALL - METFORMIN SF SUS 500MG/5ML

Recalls and Alerts

Class 2 Recall

CLASS 2 RECALL - METFORMIN SF SUS 500MG/5ML

Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the below product from pharmacies and wholesalers as a precautionary measure due to the identification level of an impurity above the acceptable limit. Following routine monitoring, the impurity, N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential, has been observed at a level above the acceptable limit

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-rosemont-pharmaceuticals-limited-metformin-hydrochloride-500mg-slash-5ml-oral-solution-pl-00427-slash-0139-el-21-a-slash-20?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c8cb9f63-892e-4ac7-826d-54d8b20db482&utm_content=immediately  

Pip code

Product description

Livery

Batch Numbers

1149822

METFORMIN SF SUS 500MG/5ML

ROSEMONT PHARMACEUTICALS LIMITED

0LL0018

1152131

METFORMIN SF SUS 500MG/5ML

ROSEMONT PHARMACEUTICALS LIMITED

0LL0018

1152149

METFORMIN SF SUS 500MG/5ML

ROSEMONT PHARMACEUTICALS LIMITED

0LL0018

 

 

Further Information

 

For stock control enquiries please contact: Customerservices@rosemontpharma.com

 

For medical information enquiries please contact: pharmacovigilance@rosemontpharma.com

 

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

 

If you have any questions, then please contact your local Service Centre Customer Services team.