Recall of six pharmaceutical products related to the DEHP incident
1 Jun 2011
The Department of Health (DH) today (June 1) ordered the recall of a registered pharmaceutical product imported from Taiwan and endorsed the voluntary recall of five pharmaceutical products manufactured by Marching Pharmaceutical Limited (MPL) as part of its follow-up action on the Di (2-ethylhexyl) phthalate (DEHP) incident in Taiwan.
Subsequent to the press announcement of the Department of Health (DH) on Monday about the 42 products containing flavouring agents, DH today so far confirmed with the importers that the flavouring agents of five of these products come from the suppliers related to the two incriminated flavouring agents suppliers in the recent DEHP incident in Taiwan. The testing results from the Government Laboratory received today showed that DEHP was detected in one of the five products.
The product, Well Tab (Registration Number HK-02886), was found to contain DEHP at a level of 1.2 ppm. Well Tab is a medicine for stomach discomfort manufactured by China Chem and Pharm Company Limited, Taiwan and imported by Kai Yuen Pharmaceutical Company in Hong Kong ("Kai Yuen"). The product is available in two sizes (100 tablets per bottle and 1000 tablets per bottle).
The level of DEHP is considered unlikely to cause acute harmful effects if taken according to the recommended dosage. DH will seek Department of Justice’s advice on possible legal actions against the importer.
DH immediately ordered recall of Well Tab from the market. Kai Yuen has set up a hotline of 2395 5763 for the recall.
"DEHP is not used as an active ingredient or an excipient. Its presence in drugs should not be expected," a spokesman for DH said.
As regards the five local products manufactured by Marching Pharmaceutical Limited reported on Monday, no DEHP was detected. However, the sample of flavouring agent, which was imported from a Taiwanese company Wei Teh Flavour & Fragance Enterprise Company Ltd (Wei Teh), contained DEHP at a level of 1.1 ppm. Although no DEHP was found in the products, the manufacturer offered to conduct a voluntary recall of all the five products. DH endorsed the recall. Marching has set up a hotline 2692 2610 for the recall.
"The recall by the manufacturer is a precautionary measure in the interest of public safety," the spokesman said.
The Marching products under recall are:
1. Deter-C 250mg Vitamin C Chewable Orange Flavoured tablets (Registration Number HK-24067)
2. Cebio Chewable Tablet Vitamin C 250mg (Orange Flavoured) (Registration Number HK-24073)
3. Cevizo 250mg Vitamin C Chewable Orange Flavoured Tablets (Registration Number HK-24074)
4. Super-C Chewable Tablets 250mg (Orange Flavoured) (Registration Number HK-24075)
5. Arthritil Powder for Oral Solution 1.5G Sachet (Registration Number HK-55430)
The five products are for Vitamin C supplement and dietary supplement for joints and cartilage respectively.
Meanwhile, the remaining Taiwanese pharmaceutical products containing flavouring agents are being tested by the Government laboratory, pending results. DH will closely monitor the laboratory results.
As far as proprietary Chinese medicine (pCm) is concerned, only one of the 529 pCm products manufactured in Taiwan carried flavouring agent. Laboratory result indicated that no DEHP was contained in the product sample. The flavouring agent did not come from Taiwan.
For safeguarding the public health, with immediate effect, all importers of orally consumed drugs are required to declare the countries of origin of the flavouring agents. If the flavoring agents come from Taiwan, the importer should prove the products are free from DEHP.