An investigation was launched by the French National Agency for the Safety of Medecines and Health (ANSM) following an order to stop selling Teva’s drug Furosemide last week when two batches were found to contain Zopiclone – an insomnia treatment also marketed by Teva – instead of the heart drug.
However, according to a report by French newspaper Le Monde, no malfunction in the packaging line has been discovered after two days of investigation at Teva Sante’s facility in Sens, Burgundy (140km from Paris) where the recalled drugs were packaged.
The paper reported that four inspectors from the ANSM could not identify any defects in either the facility’s operations or equipment.
French language radio Europe 1 continued to say given the situation, Teva believes it has been the subject of a malicious attack and all evidence for now points to human interference. From 700 of the 190,000 recalled boxes of Furosemide tested so far, none have contained Zopiclone, it was reported.
Furthermore, Europe 1 described the mix-up as a “mystery,” asking how two different products manufactured in different countries (Furosemide from Hungary, Zopiclone from Spain), packaged in separate hangars four weeks apart could have ended up in the same box.
At present, the mislabeling may have played a role in two deaths - a 91 year old man from Marseille and a 101 year old woman from Compiegne – though more cases are starting to come to light as the inquiry continues, Le Monde reported.