Recall of Allopurinol-Teva Tablets 100mg (January 16, 2012)
The Department of Health
(DH) today (January 16) instructed licensed drug wholesaler The
International Medical Co. Ltd. (International) to recall a batch of
Allopurinol-Teva Tablets 100mg (registration number: HK-57739;
batch number: 1580211) from the shelf on quality ground as black
substances were found on some tablets in two blisters of the
product.
Through its surveillance system, the DH received notification
from the Hospital Authority (HA) on January 14 that black
substances were found on some tablets of the product. DH commenced
investigation immediately.
Today, investigation results showed that no fungal elements were
found. Report from the Government Laboratory today reveals that the
black substances, which adhered on the surfaces of some tablets,
bear similar features as used hydrocarbon oil.
Hydrocarbon oil might be used in equipment for the production of
tablets. DH is investigating why used hydrocarbon oil adhered onto
some tablets of the affected batch. According to the information
available so far, the black substances were only found on a few
tablets of the affected batch and could be due to quality
issues.
According to International, the affected batch was manufactured
by Teva Pharmaceutical Works Private Ltd Co. in Hungary. A total of
22,965 boxes had been imported into Hong Kong and were supplied to
HA, local pharmacies and private doctors.
Allopurinol-Teva Tablets 100mg contains allopurinol. It is
indicated mainly for hyperuricaemia and gout. It can be sold in
pharmacies under the supervision of pharmacist.
So far, DH has not received any adverse event report in
connection with the product. International has set up a hotline
3904 3799 for public enquiries. DH will monitor the recall.
Patients using the tablets are advised to examine the tablets
before consumption. If in doubt, they should seek advice from their
healthcare professionals.
The DH spokesman says: "Here, contravention of the Public Health
and Municipal Services Ordinance (Cap 132), selling 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."
(Reprinted from HKSAR Government web page
http://www.info.gov.hk/gia/general/201201/16/P201201160442.htm
)
