Yunnan Baiyao Recall Information
Below are 2 articles found on the internet. One is the recall notice; the other is a news story. http://www.dh.gov.hk/english/press/2013/130205.html Recall of proprietary Chinese medicines with undeclared aconitum alkaloids The Department of Health (DH) today (February 5) ordered a licensed wholesaler of proprietary Chinese medicine (pCm), Fung Wah (Hong Kong) Company (operated by Honour Essence Trading Limited), to recall from consumers five pCms, namely Yunnan Baiyao capsules (registration number: HKP-00776; batch number: 48911104), Yunnan Baiyao powder (registration number: HKP-00775; batch number: 48971012), Yunnan Baiyao plaster (registration number: HKP-00255; batch number: 48971204), Yunnan Baiyao aerosol (registration number: HKP-00777; batch number: 48971107) and Yunnan Baiyao tincture (registration number: HKP-00805; batch number: 20110101C), as they have been found to contain undeclared aconitum alkaloids. The action was called for upon the DH's investigation into intelligence received. Samples of the above pCms were found to contain undeclared aconitum alkaloids by the Government Laboratory today. According to the products' registration details and the Chinese medicine literature, the ingredients in the products could not account for the presence of aconitum alkaloids as detected. Preliminary investigation found that the products were manufactured in the Mainland and imported by Fung Wah, and released to the local market for sale. Information also revealed that there are two other related pCms manufactured by the same Mainland manufacturer and imported by Fung Wah, namely 【Yunnan Baiyao】 Woundplast (registration number: HKNT-16106) and 【Yunnan Baiyao】 Aerosol (Twin pack) (registration number: HKNT-16493). As a precautionary measure, Fung Wah has also voluntarily recalled both pCms and other batches of the five above-mentioned pCms. The products were indicated mainly for traumatic injury and muscle pain. Aconitum alkaloids can be toxic. If used improperly, aconitum alkaloids can cause discomfort like numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening conditions like breathing difficulties and cardiac arrhythmia. So far no adverse event related to the use of the products has been reported to the DH. The DH has notified the Mainland drug authority for follow-up. Investigation is ongoing. Members of the public can call Fung Wah's hotline at 2553 2170 for enquiries. The DH will closely monitor the recall. According to the Public Health and Municipal Services Ordinance (Cap. 132, Laws of Hong Kong), selling any drug not of the nature, substance or quality demanded by the purchaser is liable to a maximum penalty of $10,000 and three months' imprisonment. On completion of the investigation, the DH will work with the Department of Justice for prosecution matters. The DH will also refer the case to the Chinese Medicine Council of Hong Kong for taking possible disciplinary action. The DH urged members of the public to stop using the products immediately. Those who have used the products and feel unwell should seek advice from their health-care professionals. People who have the products should submit them to the Chinese Medicine Division of the DH on 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, during office hours. Yunnan Baiyao meds in HK recall Global Times | 2013-2-6 23:43:01 By Song Shengxia The country's food and drug safety watchdog Wednesday urged Yunnan Baiyao Group, a leading Traditional Chinese Medicine (TCM) producer, to monitor side effects of its medicine to ensure safety after the Hong Kong Department of Health ordered a recall of medicine made by the company for containing an undeclared substance. The State Food and Drug Administration (SFDA) has been holding talks with managers of Yunnan Baiyao and asked the company to amend instructions for its products and add safety risk information after media reported concerns over the safety of aconitum alkaloids, a substance contained in some Yunnan Baiyao medicines, the administration said in a statement Wednesday. The toxicity of aconitum alkaloids is minimized with processing. If the company follows quality management rules and the formulation process approved by the administration, its products are safe, the statement said. On Tuesday, the Department of Health (DH) in Hong Kong announced a recall of five types of medicine produced by Yunnan Baiyao, including Yunnan Baiyao capsules, Yunnan Baiyao powder and Yunnan Baiyao plaster, because they contained undeclared aconitum alkaloids. "If used improperly, aconitum alkaloids can cause discomfort like numbness of the mouth and limbs, nausea, vomiting and peripheral weakness, and even lead to life-threatening conditions like breathing difficulties and cardiac arrhythmia," the DH said in a statement. The DH said the product safety investigation is ongoing and so far no adverse event related to the use of the products has been reported to the DH. In a statement published on its website Wednesday, Yunnan Baiyao Group said the effectiveness and safety of its medicine is unquestionable because the toxicity of aconitum alkaloids is greatly lessened after special processing by the company. "The company's medicine is a prescription drug. As along as patients follow their doctors' instructions regarding the dosage, the medicine is safe to consume," a staff member at Yunnan Baiyao told the Global Times Wednesday, speaking on condition of anonymity. The company's drugs are famous for treating open wounds, and the ingredients are closely guarded secrets protected by the State. Testing by Yunnan Baiyao found 28 cases of side effects in its medicine between 2010 and 2012, mainly involving skin allergies and itching, with no serious effects reported, the company's statement said. This is not the first time the safety of the company's medicine has been questioned. In January, the Sichuan Food and Drug Administration banned sales of Yunnan Baiyao capsules after they were found to contain elevated levels of water. "Recent concerns over the potential safety hazards of Yunnan Baiyao medicine could tarnish the company's brand image and affect sales of its sideline products such as toothpaste and shampoo, which account for an increasingly large proportion of the company's revenue," Huang Hailong, an analyst at Beijing-based Adfaith Management Consulting, told the Global Times. Yunnan Baiyao reported 9.5 billion yuan ($1.5 billion) of business revenue in the first three quarters of 2012, up 23.23 percent from the previous year. |