Sanofi-Aventis Korea voluntarily recalls diabetics treatment drugs such as Apidra Injection (ingredient name: Insulin Glulisine) and Apidra injection Solostar (ingredient name: Insulin Glulisine).

Apidra Injection

The Ministry of Food and Drug Safety (MFDS) announced on the 1st February that Sanofi-Aventis Korea recalled the two products because of ‘a safety issue’. Sanofi-Aventis Korea also notified the recall in the homepage on the 31st January.

The recall resulted from the increase in the value of the specific substance in the specific manufacture’s serial number after safety monitoring. This was released in a factory in Frankfurt, Germany. The specific substance is a kind of impurity detected in the processes to combine raw materials or make end products.

The company checked any harmful substances with a watchdog department and a toxicity assessment team. They concluded there was no harm on the drug with the manufacture’s serial number. The value of the substance was within the standard value, but Sanofi-Aventis decided to recall as a preventive measure.

The serial number of the products recalled are Apidra Injection 5F437A, Apidra injection Solostar 5F288A, 5F004A, and 5F005A etc.

lhs@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>