Recall of mislabelled prescription drug
15 Apr 2011
The Department of Health (DH) yesterday (April 14) instructed a licensed drug wholesaler, Actavis (China) Holding Limited (Actavis), to recall a batch of pharmaceutical product called “Amitriptyline Tablets 10mg (Actavis)” (Registration no. HK-22054) due to printing error in some of the labels.
The matter first came to the attention of DH when the Hospital Authority (HA) notified that in a certain batch of the above product (Batch No. AA750), bottles were found labelled with one of two expiry dates, 16/10/2014 or 16/01/2014.
The affected batch comprised 1 266 bottles of 1000-tablet each and was imported from the United Kingdom in March 2011. It was then repacked by Pharmtech (HK) Ltd. into 2 547 bottles of 500-tablet each for sale in the local market. Record shows that around 1 500 bottles have been supplied to public hospitals, pharmacies and private doctors.
Finding thus far revealed that as the correct expiry date should be three years from the date of manufacture, it should be January 16, 2014. It was likely that a printing error had somehow taken place, although the reason for the non-uniform occurrence remains to be established. There is no evidence in hand to suggest that other batches were affected. DH's investigation continues.
“DH has instructed Actavis to recall the affected batch from the market as labelling error is an offence under Hong Kong Law, the Public Health and Municipal Services Ordinance (Cap 132), the maximum penalty of which would be a fine of $50 000 and six months imprisonment. However, no safety or quality issue is involved here,” a DH spokesman explained.
“Amitriptyline Tablets 10mg (Actavis)” is a prescription drug used to treat depression and also night bed-wetting in children. It can only be sold in dispensaries on doctors' prescription and under the supervision of pharmacists.
The spokesman urged all healthcare providers and retailers to stop supplying the affected batch of products and get in touch with the wholesaler as soon as possible. Members of the public who have the affected products in hand should contact Actavis for its handling. The latter has set up a hotline 2827 9199 for public enquiries.