The Food and Drug Administration (FDA) yesterday ordered a recall of all products produced by the New Taipei City-based YF Chemical Corp (永豐化學) on the same manufacturing line as its bacteria-contaminated sodium chloride injection that caused several patients to fall ill last month.
“The recalled products include 13 batches of YU Chemical’s 10ml Calglon IV injection, which expires on Feb. 25, 2017; 96 batches of 10ml/20ml sterile water for injection with an expiration date of May 17, 2017; and 98 batches of 20ml sodium chloride injection that are due to expire on April 29, 2017,” FDA Director-General Chiang Yu-mei (姜郁美) told a news conference in Taipei.
Chiang said it was estimated that the combined recall quantity would be 16.1 million ampoules in total.
The order came about two weeks after 12 patients at the Taipei Veterans General Hospital developed fevers after being injected with 20ml sodium chloride with the batch number “273A79D” on May 18.
The administration subsequently activated a Good Manufacturing Practices-based inspection of the firm’s factory and collected samples for testing, which showed the product was contaminated with a bacterium called Ralstonia pickettii.
While none of the company’s other products were found to be contaminated, Chiang said: “The FDA ordered the recall of all items produced on the same manufacturing line due to safety concerns.”
As the firm was unable to provide documentation proving its manufacturing environment to be bacteria-free — which is a violation of the Pharmaceutical Affairs Act (藥事法) — further inspections of the company’s factory would be conducted, the agency said.
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