MHRA Class 2 Medicines Recall: Metformin Hydrochloride 500mg/5ml Oral Solution (Rosemont Pharmaceuticals Limited)

Class 2 Medicines recall: Metformin Hydrochloride 500mg/5ml Oral Solution (Rosemont Pharmaceuticals Limited)

Drug alert number: EL (21) A/20

Date issued: 25th August 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Metformin Hydrochloride 500mg/5ml Oral Solution (Rosemont Pharmaceuticals Limited), PL 00427/0139

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.

 

Batch Number Expiry Date Pack Size First Distributed
0LL0018 Nov 2021 150ml December 2020

Advice for healthcare professionals

  • Stop supplying the batches listed above 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.

Full drug alert can be viewed here.

Company contacts for further information

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

 

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