***********************************************
The Department of Health (DH) today (April 5) instructed a licensed drug wholesaler, Batou Limited, to recall all batches of Celonol 50 Tablets (registration number: HK-57702) from consumers as the drug has failed to meet relevant pharmacopoeial standards.
A DH spokesperson explained that, upon the investigation of a public enquiry, samples of Celonol 50 Tablets were collected by the DH and analysis showed that the samples had exceeded the limit for total bacterial count.
Celonol 50 Tablets contains atenolol and is used for the treatment of hypertension. It is a prescription drug and should only be used under medical supervision. Pharmacies can only sell the drug under the supervision of a registered pharmacist and upon doctors' prescription.
Celonol 50 Tablets is manufactured by Celogen Pharma Pvt Ltd in India. Batou has so far imported 1 550 boxes, among which, 864 boxes had been sold to private doctors and local pharmacies.
Microbial contamination of a pharmaceutical product may not only have the potential to affect the therapeutic efficacy of the product, but may also lead to the risk of infection for the user.
So far, the DH has not received any adverse reaction report in connection with the product. The DH's investigation is continuing.
The DH has also written to health-care professionals to alert them to the recall and to advise them to stop supplying the product to patients.
"Members of the public who are taking the product should seek advice from their doctors immediately for an alternative supply of medicines for continued treatment," the spokesperson advised.
"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," the spokesperson continued.
Batou has set up a hotline (2781 2619) to answer related enquiries. The DH will closely monitor the recall.
Ends/Friday, April 5, 2013
Issued at HKT 19:06
NNNN
