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