The ANSM, the French National Agency for the Safety of Medicines and Health Products, ordered pharmacists to stop selling Furosemide on June 7 after two batches of the drug – lots Y175 and 176 – were found to contain Teva's insomnia treatment Zopiclone rather than the heart pill.
The drug watchdog warned that heart failure patients mistakenly taking the sleeping pills instead of the loop diuretic – which is used to prevent hypertension and edema in people with cardiac problems – may not be receiving the vital treatment they need.
The organisation also said that judicial authorities in the Southern city of Marseille had opened an investigation into the death of a 91-year old heart failure patient who had reportedly been taking pills from one of the affected lots, although it stressed that no causal link has been established.
ANSM told in-Pharmatechnologist.com that Teva has recalled the affected Furosemide lots and added that it has advised pharmacists to call all patients issued with this medicine since early May to check items in their possession.
Teva did not respond to a request for comment ahead of publication, however, according to reports in the Israeli press the recall is limited to the two Furosemide batches in France. The firm also said that it is investigating if there is a direct link between the Marseilles death and the drug.
According to a report in Le Figaro ANSM inspectors are due to inspect the Teva Sante facility in Sens, Burgundy 140km from Paris where the recalled drugs were packaged.