Nine hospitals and clinics used a sodium chloride injection manufactured by New Taipei City-based YF Chemical Corp (永豐化學) that was allegedly contaminated with bacteria, the Food and Drug Administration (FDA) said.
They were: Taipei Veterans General Hospital and the Cathay General Hospital in Taipei; Sijhih Cathay General Hospital in Hsinchu; the Hungchi Women and Children’s Hospital and the Landseed Hospital in Taoyuan; the Ching Hsin Women and Children’s Hospital in Tainan; the Chingsheng Hospital in Chiayi City; the Chang Chin-yun Pediatric Clinic in Kaohsiung; and the Wen Ho Orthopedic Clinic in New Taipei City.
The FDA on Monday ordered the recall of a batch of the 20ml sodium chloride injection with the registration number “001085” after receiving reports from the Taipei General Veterans Hospital that several patients developed fevers of unknown origin after being injected with the product.
Photo: Chang Chia-ming, Taipei Times
Two of the 17 samples collected at the hospital by the FDA were found to contain a bacterium called Ralstonia pickettii.
The two belonged to the same batch of the product, numbered 273A79D, that included 54,400 ampoules in total, the agency said.
Whether the contamination occurred during manufacture or was due to improper disease management at the hospital was unknown, FDA Division of Controlled Drugs official Chen Ko-hsin (陳可欣) said.
Later yesterday, Taipei Veterans General Hospital said 12 patients had developed fevers after being injected with the solution since May 3. Four were discharged and eight remain in treatment, it added.
Ralstonia pickettii is not considered to be a major pathogen, hospital Infection Control Center director Wang Fu-der (王復德) said, adding that it generally infects only individuals with weakened immune systems.
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