Chugai Pharmaceutical Co., Ltd announced that it has begun a voluntary recall of Vesanoid capsule used as a treatment for acute promyelocytic leukemia, that Chugai manufactures and markets.
With a specific batch (K0156X1) of Vesanoid capsule imported from F. Hoffmann-La Roche Ltd., it was discovered that some bovine-derived materials sourced from Canada were used for gelatin which was used as a raw material of the capsules.
Use of bovine-derived material sourced from Canada is approved overseas, however, Japan had decided to require a partial amendment to the approval document in order to use such raw materials, in conjunction with the partial amendment to the criteria on biologically-derived raw materials enacted on March 30, 2004. Accordingly, Chugai and Roche were in agreement not to export to Japan, Vesanoid capsule which uses bovine-derived material sourced from Canada. However, the batch in question was exported to Japan due to a misunderstanding by Roche that its use in Japan had been approved. As a result of this discovery, Chugai has decided to voluntarily recall the shipped product in question.
Chugai has submitted a notification to the authorities, and on August 2, started to recall the products that have already been supplied to medical institutions and distributors by the below method.
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, and Chugai believes the same.
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.