Sanofi says injectable recall could cost company $110m
The multinational issued a voluntary recall of all of its Auvi-Q (epinephrine) injectors for anaphylaxis after discovering they may deliver inaccurate doses or not administer the drug at all. On top of the recall, “we have temporarily stopped manufacturing,” Auvi-Q products, announced Sanofi chief medical officer Paul Chew in a video address to patients.
Chief financial officer Jérôme Contaime told a Q3 earnings call on Friday, the financial impact of the recall “depends on the duration and will be accounted for in the fourth quarter. The initial estimate is a negative impact of approximately €100m on business net income.”
26 ‘malfunction’ reports
The affected Auvi-Q products are 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers, lot numbers 2081278 to 3037230, which expire between October 2015 and December 2016.
Patients in the US and Canada reported 26 cases (up to October 26) where the device appeared to malfunction while they were trying to treat allergic reactions. No deaths were associated with these cases.
Sanofi commented, “if a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life-threatening condition.”
The product is packaged with two active devices and one trainer device in a corrugate box and was distributed throughout the US via wholesalers, pharmacies and hospitals.
Chief medical officer Paul Chew said the company is working with the FDA to resolve this issue, and in the meantime patients should contact their doctors for a prescription for a rival epinephrine auto-injector.
