Three batches of Navelbine injection recalled

The Department of Health endorsed a voluntary recall of three batches of a registered pharmaceutical product Navelbine Injection by its licensed drug wholesaler, Orient Europharma Co Ltd.

This cameafter the announcement of a worldwide recall of the affected batches of the product following an out-of-trend result in content of S/D6 or epoxyvinorelbine or vinorelbine-3,6-ether found during the review of routine stability data conducted by the product's French manufacturer Pierre Fabre Medicament.  S/D6 is one major degradation substance in the product.

According to the investigation result by the product's manufacturer Pierre Fabre Medicament, the out-of-trend content of S/D6 originated from the use of a single batch of tartaric acid, a raw material in the manufacturing of Navelbine. An increased content of iron in the tartaric acid was found to be the cause. In Hong Kong, only three batches of the products were manufactured from the single batch of tartaric acid. The affected three batches are therefore recalled.

S/D6 has been shown to have equal toxic potential as the active ingredient of Navelbine Injection based on acute toxicity studies. Notwithstanding the out-of-trend content of S/D6, the product after retesting is still within the product specification.