Further recall of pharmaceutical products by Universal Pharm Lab
15 Oct 2010
The Department of Health (DH) has directed licensed drug manufacturer Universal Pharmaceutical Laboratories Limited to recall from the market 20 products manufactured by one of its production lines further to the last recall ordered on October 6, 2010.
The latest recall order followed DH's further investigation into a problem caused by a damaged sieve used in the above production line.
On October 6, 2010 following initial investigation into a complaint about a metal wire found in one tablet of its product, Bronco-DM tablets (HK-39022), DH directed the manufacturer to recall four batches of products. Immediate remedial action was taken in May by the manufacturer to replace the defective sieve. No adverse report was received.
The manufacturer has immediately suspended all production to facilitate DH investigation. Further investigation by the DH could not ascertain that other products manufactured from the same production line are not affected by the defect. As such, the DH today (October 15) directed the manufacturer to recall all products manufactured from this production line.
The products to be recalled are listed in the attachment.
The manufacturer is instructed to suspend the distribution of all tablet and capsule preparations manufactured from other production lines and has to ensure the quality of these products to the satisfaction of the DH before they could be released to the market. As a remedial measure, the manufacturer is required to submit protocol on its risk management to the DH before resumption of its production could be considered.
Investigation by the DH continues.
Two hotlines (2635 5007, 2635 5008) have been set up by the manufacturer for public enquiries, operating between 9am to 5.30pm daily. The manufacturer will announce the recall arrangement by next Monday.
Members of the public may submit the products to the manufacturer or the DH's Pharmaceutical Service at 3/F Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, during office hours.
They should consult healthcare professionals if in doubt.