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Recall of Allerex and Optodexine Eye Drops

Hong Kong (HKSAR) – The Department of Health (DH) today (August 27) endorsed a licensed drug wholesaler, Ashford Pharmaceuticals Limited, to recall from the market all batches of Allerex Eye Drops (registration number: HK-54384) and Optodexine Eye Drops (registration number: HK-54304) due to a potential quality issue.

The DH received notification from the manufacturer of both pharmaceutical products in Macau that it is recalling Allerex and Optodexine Eye Drops from the market globally. According to the Macau manufacturer, the manufacturer of one of the products’ active ingredients was found to have violated the Good Manufacturing Practice (GMP) requirements. Such a violation may pose potential risks of cross-contamination of raw materials, and hence the recall is being conducted as a precautionary measure.

“Locally, the DH’s investigation is continuing.

So far, no reports of adverse events have been received relating to the use of the products,” a spokesman for the DH said.

Allerex Eye Drops, containing antazoline and tetrahydrozoline, is an over-the-counter medicine for the treatment of allergic conjunctivitis. Optodexine Eye Drops, containing chloramphenicol, dexamethasone and tetrahydrozoline, is a prescription medicine for the treatment of eye infections.

According to the distributor, both Allerex and Optodexine Eye Drops have been supplied to local private hospitals, medical practitioners and pharmacies while Allerex Eye Drops have also been supplied to the DH’s clinics. The DH will closely monitor the recall.

Ashford has set up a hotline (2976 9949) to answer public enquiries.

“Members of the public should stop using the products and seek advice from health-care professionals if in doubt or feeling unwell after use,” the spokesman advised.