Mitsubishi Tanabe Pharma has recalled three lots of injected drugs made at its plant in Ashikaga, Japan after “some aspects of [quality] testing were inadequate.”
The move follows a report in the Asahi newspaper that investigators appointed by Mitsubishi suspect that an employee at the plant has forged safety test records over a three year period ending March 2010.
This was later confirmed by Takashi Tanaka, head of Mitsubishi Tanabe’s factory unit, who told Bloomberg that: "A male employee in his 40s at a plant in Ashikaga city, north of Tokyo, failed to complete some quality-control tests," adding thatthe worker has been sacked and operations at the facility are continuing.
The affected products are Mitsubishi prostaglandin preparation Liple (alprostadil), its adrenocortical hormone Limethason and the injectable antibacterial Pazucross.
The firm said: “[It] is taking the incident very seriously,” and offered its sincere apologies for causing concern and trouble to patients, healthcare professionals and other affected by the incident.