Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL(21)A/20

Rosemont Pharmaceuticals Limited is recalling a specific batch of Metformin Hydrochloride 500mg/5ml Oral Solution due to identification of an impurity above the acceptable limit.

MDR Number  246-08/21

Company name  Rosemont Pharmaceuticals Ltd

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

Details of the affected batch:

Active Pharmaceutical Ingredient: metformin hydrochloride

Brief description of problem
Rosemont Pharmaceuticals Limited is recalling all unexpired stock of the above 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.

Advice to Healthcare Professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Patients should be advised not to stop any treatments without consulting their relevant healthcare professional. The risks of suddenly stopping medication for type 2 diabetes is higher than the potential risk presented by the impurity.

Company contacts for further information

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

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

To access the full recall:

Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL(21)A/20