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MHRA to pharmacies: Stop supplying specific batch of metformin oral solution

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked pharmacies to “immediately” stop the supply of a specific batch of metformin oral solution, after a nitrosamine impurity was identified.

Pharmacies should “quarantine all remaining stock and return it to your supplier”, the MHRA advised yesterday (August 26) of the affected batch of Rosemont Pharmaceuticals Limited’s metformin hydrochloride 500mg/5ml oral solution.

While “very low levels” of nitrosamines have been identified in the batch, these can become harmful if consumed over a long period of time, the medicines watchdog said.

“To date, there is no evidence that this impurity has caused any harm to patients,” the MHRA stressed, and the wholesaler and pharmacy recall is just a “precautionary [measure] to prevent further exposure”.


Patients shouldn’t stop taking their medicine


Despite the recall, patients are advised to continue taking their medication and should consult their “healthcare team” as “the risks of suddenly stopping medication for type 2 diabetes is higher than the potential risk presented by the impurity”, the MHRA stressed.

Details of the affected batch are:

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

Batch number  
Expiry date
Nov 2021  
Pack size 
First distributed
December 2020

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