Recall of pharmaceutical products by Universal Pharm Lab
6 Oct 2010
The Department of Health (DH) has directed registered drug manufacturer Universal Pharmaceutical Laboratories Limited to recall four batches of products from one of its production lines following investigation of a complaint and inspection of the manufacturer's premises.
The DH yesterday (October 5) evening received a report through its established vigilance system from the manufacturer about a complaint they received regarding a metal wire found in one tablet of its product, Bronco-DM tablets (HK-39022).
The DH immediately launched an investigation against the manufacturer and according to information available so far, the piece of metal wire might have come from a sieve used during production. So far, no adverse report has been received.
Upon investigation, the manufacturer had identified a minor damage in a sieve of one of its production lines back in May this year through its regular checking. It has taken immediate remedial action to replace the defective sieve.
Bronco-DM tablets contain dextromethorphan and bromhexine which were used for cough.? The batch related to the complaint was manufactured in May 2010 with batch number 10031506 and a total of 285 bottles, each with 1,000 tablets, had been distributed to doctors and dispensaries.
As a precautionary measure, the manufacturer has been instructed to recall from the market three other batches of products manufacturered prior to the incident in May, in addition to the batch being complained about. The full list of medicines being recalled is as follows:
Uni-Zyme 30mg tablets (HK-45451) (Batch no. 10030811)
Uni-Hydrin 50mg tablets (HK-35110) (Batch no. 10031004)
Uni-Hydrin 50mg tablets (HK-35110) (Batch no. 10041206)
Bronco-DM tablets (HK-39022) (Batch no. 10031506)
Uni-Zyme tablets contain lysozyme which is used for sore throat and inflammation while Uni-Hydrin tablets contain dimenhydrinate which is used for motion sickness and vomiting.
Both Bronco-DM tablets and Uni-Hydrin tablets are Part I poisons which can only be sold in pharmacies by a registered pharmacist or under his supervision whereas Uni-Zyme tablet is an over-the-counter medicine.
Investigation by the DH continues.
Two hotlines (2635 5007, 2635 5008) have been set up by the manufacturer for public enquiries and will operate between 9am to 5.30pm starting tomorrow.
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 are advised to inspect the medicines at hand before taking them. They should consult healthcare professionals if in doubt.