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Kobayashi Pharmaceutical did not have GMP certification, and had no opportunity to have a third party check it. Under the guidelines for voluntary recalls, Kobayashi Pharmaceutical had a policy of not recalling products until a causal relationship could be established to some extent, possibly resulting in further widespread health issues. [3]
Japanese authorities on Wednesday ordered drugmaker Kobayashi Pharmaceutical to recall three dietary supplement products containing red yeast rice, or beni koji, after they were linked to two deaths.
The Liusons, a traditional Chinese family has been involved in the pharmaceutical industry since 1959 through Pacific Pharma, an importer and wholesaler of drugs. [3] In 1983, Pacific Pharma shifted to investing on generic drugs. [3] The company initially largely sold generic drugs wholesale to government hospitals. [4]
This contamination was not detected until 2018. The incident, according to medicinal chemist and pharmaceutical industry blogger Dr. Derek Lowe, points to a greater problem. Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be ...
Pharmaceutical experts who monitor the drug market say the lack of information about pharmaceutical sourcing can slow recalls and delay the pace of getting potentially harmful products off the market.
The U.S. has seen a lot of recalls due to food safety issues over the past few months. Food safety experts say there are several potential reasons for the recalls.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
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