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
