The Department of Health (DH) today (August 18) endorsed a licensed drug wholesaler, Roche Hong Kong Limited (Roche), to conduct a voluntary recall of one batch (batch number: M1611M1) of Rivotril Oral Drops 2.5mg/ml [Rivotril] [Hong Kong registration number: HK-03373] from the market due to incorrect package insert used in this batch of product.
The DH received notification from Roche today that the wrong package insert with incorrect storage condition was packed in one batch (batch number: M1611M1) of Rivotril. The correct storage condition should be “Do not store above 25℃” instead of the wrong version “Do not store above 30℃” . According to Roche, the printing error only affected the package insert while the storage condition on the outer carton is the correct one. Inappropriate storage condition may affect the efficacy of the product. The DH has requested Roche to provide a detailed investigation report as soon as possible.
Rivotril containing clonazepam is indicated for epilepsy. It should only be used under medical advice. It can also be sold on prescription and under the supervision of registered pharmacist in pharmacy.
According to Roche, 420 boxes of the affected batch were imported to Hong Kong in May 2014 and were then re-packed by its distributor. Among the imported stock, 407 boxes have been supplied to Hospital Authority, private hospitals, private doctors and one pharmacy.
So far, the DH has not received any adverse reaction report related to the product. The DH's investigation is continuing.
Roche has set up hotlines (2723 2832) to answer related enquiries. The DH will closely monitor the recall.
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