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The Department of Health (DH) today (July 11) endorsed a voluntary recall of three batches of a registered pharmaceutical product Navelbine Injection (Registration No.: HK-44009) by its licensed drug wholesaler, Orient Europharma Co Ltd, after 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.
In Hong Kong, Navelbine Injection is a prescription drug with indication for lung cancer and breast cancer. The product has two pack sizes for sale in Hong Kong, namely as 10mg/1ml and 50mg/5ml.
The three batches under recall in Hong Kong are:
1) Navelbine Injection 10mg/1ml (Batch 1P109)
2) Navelbine Injection 50mg/5ml (Batch P507)
3) Navelbine Injection 50mg/5ml (Batch P508)
These products have been distributed to public hospitals, private hospitals and private doctors.
The DH has not received any adverse event report related to the use of the medicine so far.
Orient Europharma Co Ltd has set up an enquiries hotline at 2578 7080, operating between 9am and 6pm on weekdays.
Healthcare professionals and retailers are advised to stop supplying the batches concerned to their clients. People who have used the affected product should consult healthcare providers if in doubt or feeling unwell.
Meanwhile, the DH will investigate the matter further and monitor the recall.
Ends/Monday, July 11, 2011
Issued at HKT 19:40
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