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

Published On:

25 August 2021

Published In:

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.

Company name

Rosemont Pharmaceuticals Limited

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

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

Active Pharmaceutical Ingredient: metformin hydrochloride

Brief description of the 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 for 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.

Further information

For stock control enquiries please contact: [email protected] For medical information enquiries please contact: [email protected]

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

For further information and to download the document please click HERE

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