Report says defective stopper caused vaccine discoloration: FDA

Focus Taiwan
Date: 2018/11/16
By: Chang Min-hsuen and Ko Lin 

Taipei, Nov. 16 (CNA) French pharmaceutical Sanofi Pasteur has reported that the change in color of one of its vials of flu vaccine distributed in Taiwan was caused by a defect in the vial’s rubber stopper, Taiwan’s Food and Drug Administration (FDA) said Friday.

Hung Kuo-teng (洪國登), section chief of FDA’s Division of Medical Devices and Cosmetics, said the Sanofi Pasteur report on the problematic flu vaccine suggested impurities from the defective stopper may have found their way into the vaccine.

The problem could have stemmed from the sulfur vulcanization process, make the rubber more durable and provide a tight seal, Hung said.

The French company believes the vulcanization process may have repeated itself or the temperature was too high during the process, generating sulfur compounds that may have come in contact with the vaccine and changed its color, the FDA official said.    [FULL  STORY]

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