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France investigates Teva after packaging mix-up

Some packages of diuretic furosemide found to contain sleeping pill zopiclone

ANSM: France investigates Teva after packaging mix-up

Regulators in France have reported the first findings of an investigation into Teva Pharmceutical after some zopiclone sleeping pills were found in packs of the diuretic furosemide.

The country's National Security Agency for Medicines and Health Products (ANSM) announced a recall of two batches of Teva's furosemide 40mg last week following the discovery, but this was later extended to cover all lots of the product after the death of a 91-year-old man who was taking furosemide.

Four inspectors from the Agency have this week been investigating the Teva plant that packaged the drugs, but the ANSM said yesterday that their preliminary findings that, while they were unable to ascertain what caused zopiclone to end up in boxes of furosemide, they “did not identify any major malfunction of the site”.

As a result, the site is allowed to remain open, although the investigations are still ongoing.

Meanwhile, Teva said it was implementing a systematic check of recalled boxes of furosemide 40mg, which is being conducted under supervision from authorities and will cover several thousand boxes to identify the cause of the mix-up.

The furosemide recall is the second major patient safety event that the ANSM has investigated this year, following the recall of Bayer's contraceptive pill Diane 35 and its generics after it was linked to an increased risk of blood clots.

In that instance, the EMA's Pharmacovigilance Risk Assessment Committee later made a recommendation that the drug could be used in a limited group of patients, but this was ignored by the ANSM, which upheld its complete suspension of sales pending a final decision from the EMA.

The European regulator has yet to make a public statement about the furosemide recall, although in France all patients have been asked to hand back to their pharmacists all boxes of the product issued to them to be destroyed.

Pharmacists have been told they should then offer the patient an equivalent version of furosemide from another manufacturer.

12th June 2013

From: Sales, Regulatory

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