Precautionary Recall of certain batches of Navelbine Injection (Vinorelbine Ditartrate) 10 mg/mL

Orient Europharma Pte Ltd, in consultation with HSA is conducting a voluntary recall of 3 batches of the antineoplastic agent, Navelbine® injection 10mg/mL (SIN06778P) due to an atypical trend in the degradation profile resulting in an increase of impurity S/D6 observed in these batches. The affected batches are P505, P506 and P507. The content of impurity is still consistent with the current registered specifications to product expiry. The increase in impurity is not expected to impact the efficacy of Navelbine® Injection nor increase risk to patients. The recall is a precautionary measure and all healthcare professionals are advised to stop using the affected batches.