Mitsubishi Tanabe recalls two million injectables

pharmafile | January 28, 2011 | News story | Manufacturing and Production Mitsubishi, injectables, recall 

Mitsubishi Tanabe Corp has said it will recall two million of its injectable medicines made at a facility in Ashikaga, Japan, because it cannot guarantee their quality.

“Quality testing is conducted to determine if products are suitable for shipping, and it has been confirmed that, for certain lots of these products, some aspects of that testing were inadequate,” said Mitsubishi Tanabe in a statement.

The lapse has been attributed to the actions of one worker at the plant, which is operated by subsidiary Mitsubishi Tanabe Pharma Factory. The employee failed to carry out the required quality control testing and has been replaced, said the company. Meanwhile, production at the facility continues as normal.

“We offer our sincere apologies for causing concern and trouble to patients, healthcare professionals and others affected by this incident,” it added.

The products affected by the recall include: 5mcg and 10mcg formulations of the arteriosclerosis treatment Liple (alprostadil); 2.5mg doses of corticosteroid Limethason Intravenous Injection (dexamethasone palmitate) used to treat rheumatoid arthritis; and 300mg and 500mg doses of the quinolone antibiotic Pazucross Injection (pazufloxacin mesylate).

Retention samples have been tested with no evidence of quality defects, and there have been no reports of any adverse effects to the products among patients, according to Mitsubishi Tanabe.

According to Mitsubishi Tanabe’s just-published third-quarter results, Liple sales are expected to reach 7.3 billion yen ($88 million) in fiscal 2010 (ending 31 March). The company does not break down financial figures for the other two drugs as they are outside its 20 earners, but said that the disposal of all the products “will not have a significant effect on [financial] results”.

Overall, Mitsubishi Tanabe’s third-quarter pharmaceutical sales came in at 312 billion yen, down fractionally over the same period of fiscal 2009 and impacted by price cuts in Japan’s National Health Insurance (NHI) system, although operating income rose nearly 15% to reach 69 billion yen.

Phil Taylor

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