The Department of Health (DH) today (November 14) endorsed a licensed drug wholesaler, Medreich Far East Limited, to recall all batches of three antibiotics from the market as their package inserts do not match with the registered ones.

     The three pharmaceutical products are:
 

Product name	Registration No.
Fleming Tablet 1g	HK-52242
Fleming for oral suspension 457mg/5ml	HK-56072
Fleming for suspension 228.5mg/5ml	HK-56069

     The DH received notification from Medreich that the package inserts of the above three products were different from those of the registered versions and this rendered the products unregistered. As the supply of unregistered pharmaceutical products contravenes the Pharmacy and Poisons Regulations (Cap 138A), Medreich voluntarily recalled the products from the market. The DH's investigation is continuing.

     "According to the Regulations, the sale of unregistered pharmaceutical products is a criminal offence and the maximum penalty upon conviction is a fine of $100,000 and two years' imprisonment," a spokesman for the DH said.

     The above three products, containing amoxicillin and clavulanic acid, are antibiotics and prescription medicines used for the treatment of bacterial infections.

     According to Medreich, while both Fleming suspensions have been supplied to private hospitals/clinics, local pharmacies and other licensed wholesale dealers, the tablets have also been supplied to the Hospital Authority in addition to the above locations.

     "No adverse reaction reports in connection with the affected products have been received so far," the spokesman added.

     Medreich has set up a hotline (2572 6468) to answer related enquiries. The DH will closely monitor the recall.

Ends/Monday, November 14, 2016
Issued at HKT 17:53

NNNN