TAIPEI -- Taiwan's food and drug authority will withdraw products from Y F Chemical Corp after finding contaminated sodium chloride solution caused adverse reactions in 12 patients.
Samples of the solution were found contaminated with Ralstonia pickettii during production, said Chiang Yu-mei, head of the food and drug authority.
The agency ordered a continued suspension for the related production line and withdrawal of all products produced by it, including the contaminated solution and two others, totaling more than 16.1 million vials.
Chiang said the incident is not likely to cause a shortage in the products withdrawn because other manufacturers in Taiwan have sufficient supplies.
The food and drug authority last month ordered immediate suspension of medical use and withdrawal of a batch of sodium chloride solution after 12 patients in a hospital in Taipei had fever after receiving an intravenous sodium chloride solution as of May 19. No new cases have been reported.
The drug company has been asked to conduct a thorough investigation to find out the cause for the contamination and cannot resume production until it submits certificates for bacteria control and rectifies its practice.
The company could face a fine up to 300,000 New Taiwan Dollars (9,758 U.S. dollars) for producing substandard medicine and up to 150,000 New Taiwan Dollars for violating Good Manufacturing Practice (GMP), according to the food and drug authority.
