China Bio-Immunity, a developer and marketer of proprietary vaccine-based prophylactics and therapeutics exclusively within China, has initiated a voluntary nationwide recall of the unused lots of its rabies vaccines.
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The lots are being voluntarily recalled as a precaution following a notification issued by China’s State Food and Drug Administration (SFDA) of the possibility of a flaw in the company’s rabies vaccines.
On January 12, 2009, following an inspection conducted by the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) on an approved sample of rabies vaccine submitted for batch release by the company’s operating subsidiary, Dalian Jingang-Andi Bio-Products Co(Dalian JGAD), the SFDA issued a notification on its website that there may be the possibility of a flaw in the rabies vaccines manufactured by Dalian JGAD. Preliminary results of the inspection conducted by the NICPBP have suggested the possibility of a flaw in the company’s rabies vaccines.
In conjunction with its inspections, the SFDA has requested the Liaoning Provincial Food and Drug Administration enhance its monitoring of the company’s vaccines, and has ordered a temporary shut down of the company’s production facilities. Additionally, the local SFDA has also initiated further investigation into the issue.
Quanfeng Wang, CEO of China Bio-Immunity, said: The safety and quality of our products is always our highest priority. We are in the process working with distributors and retailers to make sure the questioned products are not available for sale anywhere in China. We will continue to cooperate with the SFDA and all other governmental agencies to determine the cause of the issue and will update investors as soon as the impact on our financial performance becomes assessable.
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