The French drug overseer last week had Teva Pharmaceutical Industries ($TEVA) recall thousands of blister packs of furosemide when packages that should have contained the diuretic were found to be filled instead with the Teva sleep aid Zopiclone. It then sent inspectors into the Teva plant at Sens, Burgundy, to determine how the switch might have happened. But Teva and the ANSM say inspectors turned up no problems with methods or machines and now there is a suspicion that product tampering may be involved in the matter, which has been tied to at least two deaths.
The ANSM said in a statement on its website that four inspectors went through the packaging at the site but found no problems that would explain the mispackaged drugs. It said the inspectors, under the supervision of a bailiff, will continue to check several thousand boxes to determine how many are affected. The ANSM said it was notifying French prosecutors of its findings, which have opened a case into the packaging switch. Since police began investigating the death of a 91-year-old man believed to have taken drugs from packages marked as furosemide, there have been reports of other deaths and hospitalizations of more patients suspected of getting the mispackaged drugs. The radio report said the company intended to file a complaint about the potential tampering.
Teva has stopped shipping product from the plant. The company said in an email Wednesday that it welcomed ANSM's report that it found no problems at the plant. It said the recall had been prompted by a single pharmacist report finding Zopiclone in a furosemid package."Teva continues to conduct its internal investigation and to open and inspect blisters of Furosemide Teva 40 mg (diuretic). At this time, none of the blisters of furosemide 40 mg we have opened contained a Zoplicone tablet." It apologized for inconvenience to patients and pointed out that at this point there is no evidence that connects the reported death with its product.
A report by Europe 1 radio and cited by in-Pharmatechnologist.com pointed out that the two drugs were manufactured at different plants, furosemide in Hungary and Zopiclone in Spain, and packaged in different parts of the plant in France four weeks apart.
- the ANSM statement
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