"Bloomberg" reports that Paris prosecutors have opened an investigation into drug packaging mistakes at a Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) plant in Sens, in north-central France, which may have killed six people. The preliminary inquiry was opened today. Teva has suspended shipments from the plant.
The case involves the switching of packages of its heart failure medication Furosemide with the sleeping pill Zopiclone. France's National Agency for the Safety of Medicines and Health Products (MSNA) ordered a recall of the packaging, after the mislabeling was linked to possible patient deaths, and the hospitalization of others.
Yesterday, "Radio Europe 1" reported that MNSA suspects that product tampering may be behind the switching of the packaging, after no breakdown was found in the Furosemide production line, and that it was not possible to switch the packaging without human intervention.
Teva says that it is continuing its internal investigation into the matter and has started opening, under a court bailiff’s supervision, blister packs of furosemide, adding that, so far, the inspection has found no Zopiclone sleeping tablets inside the furosemide blisters.
Teva is cooperating in the investigation, which is apparently focused on finding an employee or other person who switched the packaging on the production line.
Teva said in repsonse, "Teva has welcomed a report from the ANSM, the French regulatory body, following an inspection at the company’s packaging site in Sens, France, after which the agency said that its preliminary findings did not identify any faults in the organization, practices or the equipment at the site."
"Teva France this week recalled all batches of furosemide Teva 40 mg tablets, a medicine used in the treatment of heart disease, following one pharmacist report indicating that a blister pack from one of these batches included a tablet that was not furosemide 40mg but zopiclone 7.5mg, a medicine used for the treatment of insomnia."
"Teva continues to conduct its internal investigation and to open and inspect blisters of furosemide Teva 40mg (diuretic). At this time, none of the blisters of furosemide 40mg we have opened contained a zoplicone tablet."
"Teva France has apologized for any inconvenience to its patients, and the company will work to complete its review as soon as possible. Other markets and other Teva France products are not affected by the recall."
"Some media reports have linked at least one patient death in France to this issue. Teva has expressed its sorrow to hear of the death of any patient, but the company has not at this time received any evidence that this was connected to the recalled product; and is cooperating fully with the authorities in their investigations."
Published by Globes [online], Israel business news - www.globes-online.com - on June 13, 2013
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