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Over 32,000 Boxes of Lisinopril Recalled in France Over Labeling Error

The ANSM initiated the recall due to a printing defect on blister packs that could cause dosing confusion, with no impact on tablet quality.

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Overview

  • The recall affects 32,640 boxes of Lisinopril in four specific 5 mg lots distributed by Viatris in France.
  • A printing defect on the blister-pack aluminum could lead patients to mistakenly take multiple pills on certain days.
  • The ANSM confirmed the therapeutic quality of the tablets and reported one non-serious overdose incident involving confusion.
  • Symptoms of potential overdose include fatigue, balance issues, low blood pressure, and possible renal function impairment.
  • Supply shortages are not expected, as alternative generics and compliant new lots will ensure continued availability.