United Press International - Monday, 23 July 2001
A Baxter spokeswoman said the recall is just precautionary because the virus would have been killed in the pasteurization process used to make the treatment.
Spokeswoman Tanya Tyska would not say how much of the solution was produced or shipped to hospitals and health centers in the United States. She said Baxter still has a substantial amount of the lot in stock but has been shipping the treatment since February.
Albumin (Buminate) 5 percent solution is used to treat burn victims intravenously. It is made from blood plasma.
Tyska said the contamination was discovered as a result of a PCR test that was performed in addition to those required by the Food and Drug Administration. The test is required by some foreign countries.
"The product did meet FDA specifications for release. There are no adverse events reported to date," Tyska said. "The recall is being conducted for quality reasons, not safety reasons. Pasteurization destroys the virus."
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