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#23-505 Hood Road,
Markham, ON, Canada,
Re: Urgent Recall Xuduan granules concentrated tea sachets in 1.1g/ sachet from E-Fong. Lot numbers are 1310617 (exp date: May 2018), 1501608 (exp date: Dec 2019), 1506607 (exp date: May 2020), 1606627 (exp date: May 2021)
Health Canada has categorised this risk as Type I and Type II. While the manufacturer disagrees with the findings and the classification, we are taking action to comply with Health Canada's request to recall all Xu Duan products as they requested .
We have not received the lab report from Health Canada. We have only been informed by Health Canada that they found a "trace amount" (usually 10ng/ml=0.00001mg/ml?) “Mycophenate” in the Xuduan granules test samples. E-Fong manufacturer confirms this product Xuduan is a pure natural herbal tea extract and therefore, whatever compound that is found in the product should be a naturally occurring compound. Natural Phenolic compounds are the dominant antioxidant components and widespread, naturally presence in plants, herbs and fruits which are the most interesting topic for the researchers nowadays. E-Fong claims there have not been any reported side effects of Xuduan from users since 1995..
Please stop selling and distributing E-fong Xu Duan granules concentrates tea products with the above listed Lot numbers and return them to us ASAP..
Please check if you still have Xuduan with the above listed Lots in stock and return them to us ASAP !
Please also complete the attached form and fax ( 905-480-1200) to us ASAP!
Return all stock listed above lots to:
23-505 Hood Road, Markham, Ontario, L3R5V6
Thank you for your cooperation and support in the recent recall request from the Health Canada Department for the product Xuduan herbal granules. We understand the worry and burden for this recall. we hope to convey some key facts:
1. According to the scientific literature, there is no mycophenolic acid (MPA, Mycophenolate). The mycophenolic acid in original fresh herbal Xuduan. According to the SOP (standard of procedure) of the Pharmacopoeia of PR China, all stansard raw materilas Xuduan have been procesured with a “sweating” period, wich will produced natural MPA. Du to the procedure, all Xuduan (including traditional raw materilas and all manufacturers' concentrated Products) must contain mycophenolic acid (MPA).
2. The manufacturers strictly follow SOP to prepare concentrated granules of traditional Chinese medicine. At any time during the manufacturing process, Xuduan granlues have never been added MPA by Yifang pharmaceutical. It should be noted that the manufacturer does not manufacture any mycophenolic acid products;
3. The product of Xuduan contained mycophenolic acid (MPA), MPA contained in Xuduan granules produced by Yifang Pharmaceutics and all other herbal manufacturers is a natural chemical component produced by nature. It is not included in the list of prescription drugs. In addition to the concluding statement published on the website of Health Canada, Guangdong Yifang Pharmaceutical Co., Ltd. does not Acknowledge this conclusion
4.According to the policy of Health Canada, the product of Xuduan herbal granules is sold as a compounding material formula and is not marketed as a product that requires a non-prescription natural health product license (NNHP). Raw materials do not require the Drug identification Number (DIN) or Natural Health Product Number (NPN). The Ministry of Health’s notice violates the relevant regulations of the Ministry of Health’s non-prescription natural health department. It is wrong to point out that the product is an unauthorized product on the market. The company hereby solemnly announces to the public that this statement is related to the Ministry of Health. The regulations of the relevant departments are completely inconsistent.
5. Each 10 grams (gram) of the Xuduan product contains about 10 nanograms of natural MPA, that is, 0.000005 milligrams (mg) of natural MPA per gram of Xudusn granules, and the prescription purified MPA is 1 gram per tablet. 3 grams per day is required, and the risk mentioned by the Ministry of Health is long-term taking. If the patient takes any Xuduan of a hundred tons of daily product, there is a risk as stated by the Ministry of Health.
We look forward to providing you with more information as we continue to discuss this matter with the Canadian Health Department. If you have any questions, please feel free to contact us.