Batch Recall of Keppra Oral Solution 100mg／ml
The Department of Health (DH) today (November 26) endorsed a licensed drug wholesaler, GlaxoSmithKline Ltd (GSK), to recall one batch of Keppra Oral Solution 100mg/ml (Hong Kong Registration number HK-54926) from the market because some of the product’s label does not match with the registered one.
DH received notification of GSK that some unregistered French packs of Keppra Oral Solution 100mg/ml (HK-54926) were found to be mixed up in Hong Kong registered packs in a recent shipment of one batch (Lot. No. 1183) of the product. Although the product content is the same, the French packs bear a label different from that of the registered one and renders the product unregistered. Since the supply of unregistered pharmaceutical product contravenes the Pharmacy and Poisons Regulations (Cap. 138A), GSK voluntarily recalls the product from the market. DH's investigation is continuing.
The above product, containing levetiracetam, is a prescription antiepileptic drug. According to GSK, the product has been supplied to the Hospital Authority, private doctors and a pharmacy.
So far, the DH has not received any adverse drug reaction report related to the affected product.
GSK has set up a hotline (3189 8765) to answer related enquiries. The DH will closely monitor the recall.
Reposted from HKSAR Government webpage: