Health: More than 30,000 boxes of hypertension treatment recalled in France
On Tuesday, the ANSM recalled several batches of Lisinopril, a generic drug for hypertension and heart failure.
In case of overdose, fatigue, balance problems, hypotension and "impaired renal function may occur" may occur, warns the ANSM. Illustrative photo Sipa
More than 32,000 boxes of a generic drug for hypertension and heart failure, Lisinopril, have been recalled in France due to a "printing defect" on the blister packs "which could lead to a risk of overdose," the French National Agency for the Safety of Medicines (ANSM) said on Tuesday.
"Confusing"The quality of the tablets marketed by the American laboratory Viatris "is not in question" but "the inscription on the aluminum foil of the blister pack can be misleading because it suggests that several tablets should be taken on certain days," the ANSM stated in a press release.
In total, four batches of Lisinopril dosed at 5 mg are affected (batches 8172295, 8189879, 8172296, 8192737), or 32,640 boxes, according to a count obtained from the ANSM.
In case of overdose, fatigue, balance disorders, hypotension, and "impaired renal function may occur," warns the drug's guardian. One case of overdose accompanied by a non-serious confusional state has been reported, according to the ANSM.
Alternatives availableUntil new batches with compliant blister packs become "available soon," no supply shortage of Lisinopril is expected following this recall, according to the agency, because "alternatives are available."
Other generic manufacturers, such as Biogaran, Teva, Zentiva, Sandoz and Arrow, offer this molecule, according to the Vidal database on drugs in France.
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