Class 2 Medicines Recall: Rosemont Pharmaceuticals Limited, Metformin Hydrochloride 500mg/5ml Oral Solution, PL 00427/0139, EL (21)A/20
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| Class | Class 2 |
|---|---|
| Type | Medicines recall/notification |
| Issued | 25 Aug 2021 |
| Reference | EL (21)A/20 |
| Company | Rosemont Pharmaceuticals Limited |
| Product licences | PL 00427/0139 |
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: Customerservices@rosemontpharma.com For medical information enquiries please contact: pharmacovigilance@rosemontpharma.com
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.