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Recalls

Auvi-Q Recalls Epinephrine Auto-Injectors

Updated Oct. 29, 2015

adult-children-injectionBoth child and adult Auvi-Q auto-injectors have been recalled.

All Auvi‑Q epinephrine auto-injectors on the market in the United States are being voluntarily recalled, Sanofi US, the product’s manufacturer, has announced.

Both the 0.15 mg (child) and 0.3 mg (adult) strengths are being recalled. The company says some units have been found to potentially have inaccurate dosage delivery.

Sanofi US said it has received 26 reports of suspected device malfunctions in the U.S. and Canada, as of Oct. 26, 2015. The consumer reports of malfunctions have yet to be confirmed.

The company says it is arranging for return and reimbursement of all auto-injectors currently on the market, which include lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. In Canada, Sanofi Canada also issued a voluntary recall of its auto-injectors sold under the Allerject brand name.

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Sanofi US notes that it enacted the recall because “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.” No fatalities have been reported.

What to Do if You Own the Device

• Sanofi US advises consumers who own Auvi-Qs to immediately contact your physician or healthcare provider for a prescription for an alternate epinephrine auto‑injector (EpiPen or Adrenaclick).

• In the event of a life‑threatening allergic reaction (anaphylaxis), patients should only use their Auvi-Q device if another epinephrine auto‑injector is not available, and then call 911 or local medical emergency services.

People with an Auvi‑Q device are being asked to email cs@sanofi.com or to call either 1-877-319-8963 or 1‑866‑726‑6340, Monday through Friday, 8 a.m.-8 p.m. ET for information on how to return Auvi‑Q devices.

• Sanofi US says details about reimbursement will be available shortly on www.auvi‑q.com. The company says patients will need to pay for their replacement device, but Sanofi US will reimburse patients for new auto‑injectors with proof of purchase.

Reports of adverse reactions involving the Auvi-Q can be made directly to the FDA here.

View video statement from Sanofi US chief medical officer here.
Plus additional Q&A on this page.

 

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