Recall of chromium-tainted proprietary Chinese medicines Ho

[herbsandhelpers]

Recall of chromium-tainted proprietary Chinese medicines

Hong Kong (HKSAR) - The Department of Health (DH) today (May 6) instructed a licensed proprietary Chinese medicine (pCm) manufacturer, Hong Kong Medicine Manufactory, to recall from shelf a pCm, Germany Wintex Brand Herbal Sep Capsules (registration number: HKP-09565).

"The recall follows the investigation of an intelligence related to the above pCm, which is about the chromium content in the gelatin capsules of the pCm suspected to be exceeding the recommended limit of 2ppm, as stated in the Pharmacopoeia of the People's Republic of China. DH conducts investigation immediately after receiving the intelligence," a DH spokesman said.

"Preliminary test results from the Government Laboratory revealed that the gelatin capsule of a sample of Herbal Sep Capsules contained chromium at a level of 84ppm, while the test results of other samples are still pending," the spokesman added. 

"While investigation is on-going, preliminary information showed that the capsule of the affected pCm was obtained in Guangdong in the Mainland.

DH has liaised with the authority in the Mainland for their information and follow up," the spokesman said. 

"Chromium exists naturally in the environment and is an essential nutrient in food, and the existence of chromium in gelatin capsule can be expected because of its ubiquitous nature. Ingestion of very large amount of chromium may lead to respiratory, cardiovascular, gastrointestinal, hepatic and renal damage and potentially death, and chronic exposure could be carcinogenic," the spokesman elaborated.

"Nonetheless, for the present case, if one consumes the affected pCm according to its dosage instruction, the level of chromium detected are considered unlikely to cause acute harmful effects by taking reference to the recommendation made by the World Health Organization," he stressed. 

Members of the public can call the manufacturer's hotline at 2421 6382 for related enquiries. DH will closely monitor the recall.

Since incidents of chromium-tainted capsules were reported in the Mainland, DH has written to all product certificate holders of pCm urging them to examine their products to ascertain source of their capsules, and submit laboratory test reports for chromium should empty capsules are supplied by the Mainland. DH also tests samples of pCm capsules via the surveillance scheme. 

"DH will continue investigation and closely monitor the situation of chromium-tainted capsules incidents in the Mainland," the spokesman said.

"Here, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance Cap. 132, that selling any drug not of the nature, substance or quality demanded by the purchaser might also have occurred. The maximum penalty involved here is $10,000 and three months' imprisonment.

On completion of the investigation, we will work with the Department of Justice regarding possible prosecution," the spokesman said. 

The spokesman urges those members of the public who have purchased the pCm to stop using it immediately and surrender the product to DH at 16/F, Two Landmark East, Kwun Tong, Kowloon.

For those who have used the product and feel unwell, they should seek advice from their healthcare providers as soon as possible. So far, DH has not received any adverse report related to the product.

Source: HKSAR Government

Total recall of proprietary Chinese medicines in capsule dose form by Hong Kong Medicine Manufactory

Hong Kong (HKSAR) - The Department of Health (DH) today (May 7) endorsed the recall of all registered proprietary Chinese medicines (pCms) in capsule dose form manufactured by a licensed pCm manufacturer, Hong Kong Medicine Manufactory, from shelf as part of its follow-up action on the chromium-tainted gelatin capsule incident.

"Subsequent to DH's press announcement yesterday (May 6) about the recall of a pCm, named Germany Wintex Brand Herbal Sep Capsules (Registration number HKP-09565) from Hong Kong Medicine Manufactory, the test results from the Government Laboratory received today showed another two pCms in capsule dose form, namely [ED-HO] HVO Lo Ling Capsule (Registration number HKP-12608) and [Germany Herbs Brand] Pharmastone (Registration number HKP-11318), manufactured by the same manufacturer, contained chromium in the capsule at a level of 51ppm and 9.3ppm respectively. These exceed the recommended limit of 2ppm, as stated in the Pharmacopoeia of the People's Republic of China. Other than the above-mentioned pCms, the remaining samples, including two empty capsules, were found within the recommended limit," a DH spokesman said.

"Although the investigation is on-going, the Department considered that a total recall of all the capsule dose form pCms manufactured by Hong Kong Medicine Manufactory is warranted in the interest of public safety.A total of 35 capsule dose form pCms is involved.The list of the products is shown in the Annex," the spokesman remarked.

"Preliminary information showed that the capsules of the above affected pCms were obtained from the Mainland.

DH has liaised with the Mainland authority for their further information and follow up," the spokesman continued.

"For the aforementioned cases, if one consumes the pCms according to their respective dosage instruction, the level of chromium detected is considered unlikely to cause acute harmful effects by taking reference to the recommendation made by the World Health Organization, " he stressed.

Members of the public can call the manufacturer's hotline at 2421 6382 for related enquiries. DH will closely monitor the recall.

The spokesman reiterated that since incidents of chromium-tainted capsules were reported in the Mainland, DH has written to all product certificate holders of pCm urging them to examine their products to ascertain source of their capsules, and submit laboratory test reports for chromium should empty capsules be supplied by the Mainland. DH also tests samples of pCm capsules via the surveillance scheme.

"DH will continue investigation and closely monitor the situation of chromium-tainted capsules incidents in the Mainland," he said.

The spokesman urges those members of the public who have purchased the pCms to stop using it immediately and surrender the product to DH at 16/F, Two Landmark East, Kwun Tong, Kowloon.

For those who have used the pCms and feel unwell, they should seek advice from their healthcare providers as soon as possible. So far, DH has not received any adverse report related to the products.

Source: HKSAR Government