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The Department of Health (DH) today (August 8) endorsed a licensed drug wholesaler, Novartis Pharmaceuticals (HK) Ltd (Novartis), to recall all batches of Spersallerg Eye Drops (HK-29793) from the market due to potential quality issue.
DH received notification from Novartis this evening that the product's manufacturer in Switzerland is recalling all batches of Spersallerg Eye Drops globally from the market. According to Novartis, the manufacturer of one of the product's active ingredients was found to have violated the Good Manufacturing Practice (GMP) requirements. Such violation may pose potential risk of cross-contamination of the raw material; and hence the recall is conducted as a precautionary measure.
DH investigation is continuing.
So far, no adverse events have been received relating to the use of the product.
Spersallerg Eye Drops, containing antazoline and tetrahydrozoline, is an over-the-counter medicine for the treatment of allergic conjunctivitis.
According to the distributor, the product has been supplied to the Hospital Authority, DH clinics, private hospitals, medical practitioners, pharmacies and medicine stores. The product has also been exported to Macao. DH will closely monitor the recall.
Novartis has set up a hotline (2882 5222) to answer public enquiries.
"Members of the public should stop using the product and seek advice from health-care professionals if in doubt or feeling unwell after use," a DH spokesman said.
Ends/Friday, August 8, 2014
Issued at HKT 20:27
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