Medicine recalls
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| Batch recall of Anexate 0.5mg/5ml Injection |
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The Department of Health (DH) today (August 21) endorsed a licensed drug wholesaler, Roche Hong Kong Ltd. (Roche), to recall one batch (batch number: F0119F03) of Anexate 0.5mg/5ml Injection (Hong Kong registration number: HK-30501) from the market due to a quality issue.
The DH received notification from Roche today that the manufacturer in France is conducting a voluntary recall on certain batches of the product following particulate matters found in one ampoule of the product. Root cause of the issue is still under investigation. The DH has requested Roche to provide full investigation report and to confirm if other batches could be affected.
Anexate 0.5mg/5ml Injection (containing flumazenil) is a prescription only medicine and used as an antidote due to benzodiazepines intoxication.
According to Roche, 18 boxes (containing 5 injections per box) from the affected batch have been supplied to the Hospital Authority but none of these 18 boxes were used.
The DH will closely monitor the incident.
Ends/ Friday, August 21, 2015
Issued at HKT 17:30 |
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