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Product Recalls and Safety Alerts

Total recall of Ospexin Cap 500mg and 250mg (March 7, 2012)

Total recall of Ospexin Cap 500mg and 250mg The Department of Health (DH) today (March 7) endorsed the voluntary recall of all batches of Ospexin Cap 500mg (HK-33816) and Ospexin Cap 250mg (HK-33817) from consumers by a licensed drug wholesaler, Novartis Pharmaceuticals (HK) Ltd (Novartis), on quality grounds.

The DH received notification from Novartis today that the products' Austrian manufacturer, Sandoz GmbH, decided to recall the two products as they had failed several tests during an ongoing stability study.

According to Novartis, when the products were stored at 30 degrees Celsius and 75 per cent relative humidity for 12 months, the tests on dissolution, water content and capsule shell colour were found to be unsatisfactory. Preliminary investigation revealed that the problem could be due to the ineffectiveness of the packing materials in protecting the product from moisture under the above storage conditions.

A DH spokesman said, "The DH has not received any adverse event report in connection with the products so far."

Ospexin Cap 500mg and Ospexin Cap 250mg contain cephalexin and are antibiotics for bacterial infections. They can only be sold on prescription and under the supervision of pharmacists at registered pharmacies.

According to Novartis, the two products were supplied to hospitals of the Hospital Authority and private hospitals, DH clinics, private doctors and pharmacies. Ospexin Cap 500mg was also exported to Macau. The DH has informed public and private hospitals and relevant health-care professionals about the recall.

Novartis has set up a hotline at 2881 5811 to answer related enquiries. Members of the public can contact Novartis for recall arrangements or submit the products to the DH Drug Office at 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, for disposal.

The DH will closely monitor the recall.

The spokesman said, "Here, contravention of Section 52 (1) of the Public Health and Municipal Services Ordinance (Cap 132), selling a drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is $10,000 and three months' imprisonment. The DH will seek the Department of Justice's advice on further action on completion of the investigation.

"Members of the public who have used the products and are either in doubt or feeling unwell should seek advice from their health-care professionals."

(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201203/07/P201203070460.htm )