July 11, 2011

The Department of Health today endorsed a voluntary recall of three batches of Navelbine Injection (HK-44009) by its wholesaler Orient Europharma.
 
The three batches are 10mg/1ml (Batch 1P109), 50mg/5ml (Batch P507) and 50mg/5ml (Batch P508).
 
There has been a worldwide recall of the batches due to an out of trend result in the 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 manufacturer, the out of trend content of S/D6 originated from the use of a single batch of tartaric acid, a raw material for the manufacture of Navelbine. An increased content of iron in the tartaric acid was found to be the cause.
 
Only three batches of the products in Hong Kong were manufactured from the single batch of tartaric acid.
 
S/D6 has been shown to have equal toxic potential as the active ingredient of Navelbine Injection based on acute toxicity studies. Not withstanding the out of trend content of S/D6, the product after retesting is still within its specification.
 
In Hong Kong, Navelbine Injection is a prescription drug with indication for lung and breast cancer. The product has two pack sizes for sale in Hong Kong, namely as 10mg/1ml and 50mg/5ml. They have been distributed to hospitals and clinics.
 
Orient Europharma has set up an enquiry hotline 2578 7080.