"Radio Europe 1": French health authorities found that Teva's heart medication could only have been repackaged by human intervention.
French language "Radio Europe 1" reports that Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) believes that product tampering is behind the switching of packages of its heart failure medication Furosemide with the sleeping pill Zopiclone, after no breakdown was found in the Furosemide production line. "Radio Europe 1" adds that Teva will file a complaint about the incident.
"Radio Europe 1" says that, in the past two days, France's National Agency for the Safety of Medicines and Health Products (MSNA) investigated the plant where Furosemide is produced, and concluded that it was not possible to switch the packaging without deliberate human intervention.
"Radio Europe 1" says that Teva therefore concludes that this is a case of malicious tampering.
On Sunday, it was reported that MSNA ordered Teva to recall two batches of Furosemide 40 mg tablets, a prescription drug. The packaging of the drug in packages of Zopiclone has reportedly caused the death of several patients and the hospitalization of others. Teva said in response, "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 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," Teva concluded.
Published by Globes [online], Israel business news - www.globes-online.com - on June 12, 2013
© Copyright of Globes Publisher Itonut (1983) Ltd. 2013
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