A QC lapse has led Mitsubishi Tanabe Pharma to recall 2 million doses of three parenterals. The company says that for certain lots of the products, some aspects of pre-ship testing didn't make the grade.
The Osaka-based drugmaker says that it conducted quality testing of retention samples from its Ashikaga plant, north of Tokyo, and found no quality problems. Bloomberg reports that a male employee in his 40s failed to complete some quality-control tests. The worker has been replaced and production has resumed.
Among the recalled products are specific dosage forms of erectile-dysfunction drugs alprostadil and Prostaglandin E1, anti-inflammatory limethason, a synthetic adrenocortical hormone, and an anti-bacterial.
For Mitsubishi, it's at least the second recall in two years, Bloomberg says. The drugmaker recalled a blood-plasma product in 2009 because of manipulated data.
- see the Mitsubishi announcement
- here's the article