Mitsubishi Tanabe Pharma Starts Voluntary Recall of Injection Solution Products

TOKYO, Jan. 26 -- (Kyodo) -- Mitsubishi Tanabe Pharma Corp. on Wednesday initiated a voluntary recall of three injection solution products that one of its subsidiaries may have shipped without conducting quality tests.

"We apologize for causing trouble to many people, including patients and medical care providers," the Osaka-based drugmaker's President Michihiro Tsuchiya said when announcing the voluntary recall at a press conference in Tokyo.

The company said a plant of Mitsubishi Tanabe Pharma Factory Ltd. in Ashikaga, Tochigi Prefecture, skipped the quality tests for some product lots. There have been no reports of damage to health so far, according to the company.

The products subject to the recall include certain lots of Liple, a prostaglandin E1 preparation, Limethason Intravenous Injection, a synthetic adrenocortical hormone, and Pazucross Injection, a quinolone antibacterial agent. The total amount of solutions involved is roughly equivalent to 2 million syringes, according to Mitsubishi Tanabe Pharma Corp.

In a related move, Taisho Pharmaceutical Co. announced the same day that it has started recalling another prostaglandin E1 preparation called Palux, which was produced by Mitsubishi Tanabe Pharma Factory and is sold by Taisho.

Tsuchiya said his company has launched a crisis management committee to look into the causes of the incident and work out preventive measures.

The Health, Labor and Welfare Ministry and the Tochigi prefectural government inspected the plant in question on Wednesday. The drugmaker told the ministry on Monday that the subsidiary had failed to test the levels of heavy metals and fine particles in some of the product lots.

The company added such tests were conducted at the Ashikaga plant between 2002 and 2010 by an employee in his 40s. The plant has admitted that he failed to carry out some of the quality control checks required under a ministry ordinance.

Mitsubishi Tanabe Pharma Corp. said the employee initially denied allegations about his failure to complete the checks during an in-house investigation prompted by a whistle-blower at the plant. But he later backtracked during another probe led by a team of lawyers hired from outside the company.

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