Today (27 March 2013), the Department of Health (DH) instructed a licensed drug wholesaler, Healthcare Pharmascience Ltd. (HPL), to recall all batches of a pharmaceutical product, namely Pharmaniaga Clarithromycin Tablet 250 mg (registration number: HK-52623) from shelves because an unapproved product insert is used in the product package. Pharmaniaga Clarithromycin Tablet 250 mg is an antibiotic indicated for the treatment of infections.
Under the surveillance system of the DH, it was found that the above product is using an unapproved product insert, which rendered the product an unregistered pharmaceutical product under the Pharmacy and Poisons Regulations (Cap 138A). The unapproved product insert has included, in addition to Pharmaniaga Clarithromycin Tablet 250mg, information of another dosage form of the product.
According to the information of HPL, the product was supplied to private doctors and local pharmacies as well as exported to Macau. HPL has set up a hotline at 3472 8133 to answer public enquiries.
Members of the public who are using the product should consult their health care providers if in doubt or feeling unwell.
Reprinted from HKSAR Government web page:
http://www.drugoffice.gov.hk/eps/news/Recall_of_Pharmaniaga_Clarithromycin_Tablet_250_mg_%28English_only%29/consumer/2013-03-27/en/19381.html