Japan's Chugai Pharmaceuticals is voluntarily recalling almost 2000 bottles of Vesanoid capsules (tretinoin) after the drug was found to contain unapproved bovine-derived material from Canada.
Almost 200,000 pills, which are manufactured by Roche but packaged and labelled in Japan by Chugai as a treatment for acute promyelocytic leukaemia, will be destroyed as a result of the recall, which occurred after the mistaken importation of the pills containing bovine-derived material from Canada.
While many countries approve the importation of drugs that contain Canadian-sourced bovine-derived material, Japan is one country which has not approved such material sourced from Canada unless a partial amendment to approval documents has been filed prior to importation.
Chugai and Roche were in agreement not to export to Japan, Vesanoid capsules which used gelatine as a raw material in the capsule coating that had been derived from Canadian-sourced bovine-material.
But the batch in question (K0156X1), involving 1,998 bottles with 100 capsules in each bottle, was exported to Japan due to a "misunderstanding" by Roche that the products had been approved in Japan, a statement released by Chugai said.
The error was found after reconfirming the origin of the material with Roche.
Chugai would not comment on how the misunderstanding occurred, when contacted by in-PharmaTechnologist.com.
But in a statement the company said: "Chugai wishes to express its sincere apologies for having caused inconveniences to patients and healthcare professionals. In collaboration with Roche, Chugai intends to do its utmost to strengthen its setups to prevent similar incidents from recurring in the future."
Chugai has submitted a notification to the authorities and began recalling products last week that had already been supplied to medical institutions and distributors.
These products would be destroyed.
Speaking to in-PharmaTechnologist.com, a Chugai spokesman said: "In theory these could be used in other countries where bovine-derived material sourced from Canada is approved, but we will just destroy them."
He did not expect there to be a large financial loss as a result of the recall.
The bovine-derived raw material sourced from Canada used in the products has been officially certified by the European Directorate for the quality of Medicines (EDQM), and its use is permitted in Europe and other countries since no problem is said to exist with its safety.
Bovine-derived material is approved in Japan, but is dependent on the source country.
Restrictions on bovine-derived material relate to the threat of the disease bovine spongiform encephalopathy (BSE), mad cow disease, in cattle. It is believed the disease can be passed to humans causing variant Creutzfeldt-Jakob disease (vCJD).
Since May 2003, there have been nine cases of BSE being detected in cattle in Canada.
In February, Japan reported its 32nd BSE case since 1986.
In January this year, the US Food and Drug Administration (FDA) announced it was planning to ban bovine-derived materials used in the production of medicinal products to protect the public against vCJD.
A variety of bovine-derived materials have traditionally been used in the manufacture of biological and pharmaceutical products, including milk and milk derivatives (such as lactose), meat extracts, bovine serum, bovine bone gelatine and beef tallow derivatives.