Class 2 Medicines Recall: Aventis Pharma Limited (t/a Sanofi), Largactil 50mg/2ml Solution for Injection, EL (20)A/56

Sanofi is recalling specific batches due to out of specification results obtained for the impurity chlorpromazine sulphoxide, which was suspected to be caused by increased oxidation as a result of higher oxygen content in the headspace of the ampoules.

Medicines and Healthcare products Regulatory Agency