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Posted 22 December 2015 | By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there.
The agency has already detected hydrogen cyanide contamination in two shipments of drugs from Tianjin-based Tianjin Tianyao Pharmaceuticals Co., approximately 30 kilometers (18 miles) from the explosion site. The contaminated shipments have been stopped and will not be allowed in the US, the agency said, noting that it is working with the Chinese Food and Drug Administration (CFDA) on this issue.
“While information related to the explosion is limited, more than 40 different types of chemicals were discovered at the blast site,” FDA says, noting it has increased monitoring to prevent the import of drugs that may be contaminated by these toxic chemicals.
Since the explosion, Tianjin Tianyao also sent two other drug shipments for compounding to the US that were tested and released after hydrogen cyanide was not detected in the shipments.
“It is the responsibility of companies that obtain drugs - including finished drug products, active pharmaceutical ingredients (APIs) and excipients - from the Tianjin City region to take appropriate precautions to ensure the quality of these products before they are distributed and/or used to further manufacture or compound drugs or drug products,” FDA said.
The notice from FDA comes as GlaxoSmithKline has already closed its manufacturing site in Tianjin as it undergoes repairs from one of the explosions.
CDER Alert: FDA Warns of Potential Contamination of Drug Shipments from Explosions in Tianjin City
Tags: FDA, Tianjin, CFDA, chemical explosion, GSK
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