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news.Sanofi US is voluntarily recalling all Auvi-Q injections used for severe allergic reactions due to potential inaccurate dosage delivery.
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The recall affects all Auvi-Q products on the US market and includes both the 0.15 mg and 0.3 mg strengths.
It includes lots number 2299596 through 3037230 with expiration dates from March to December 2016.
Auvi-Q is designed to treat anaphylaxis, a potential life-threatening condition, in patients who are at risk or who have a history of such reactions.
Sanofi said an inaccurate dose could lead significant health consequences, including death. The company has received 26 reports of suspected device malfunctions in the United States and Canada as of 26 October 2015.
The company said there was no confirmation on the reports with patients describing symptoms of the underlying hypersensitivity reaction. No deaths have been reported.
Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. It was distributed in the US through wholesalers, pharmacies and hospitals.
The US Food and Drug Administration approved Auvi-Q in August 2012. The company said the injection is for immediate self (or caregiver) administration and does not take the place of emergency medical care.