October 30, 2015
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Sanofi issues voluntary recall of Auvi-Q

Sanofi US is recalling its Auvi-Q epinephrine injections due to a potential "inaccurate dosage delivery," according to a press release.

The voluntary recall involves all Auvi-Q on the market for retailers, hospitals and consumers, including 0.15 mg and 0.3 mg strengths in lot numbers 2299596 through 3037230, which expire March 2016 through December 2016.

The company said that it has received 26 reports of suspected device malfunctions in the United States and Canada as of Oct. 26. According to Sanofi, patients described symptoms of the "underlying hypersensitivity reaction" after using Auvi-Q. There have been no fatal outcomes reported, and the reports have not been confirmed.

Sanofi recommends that all consumers affected by the recall contact their health care provider immediately to obtain a prescription for an alternate epinephrine auto-injector.

"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," the company said in the release. "Customers should contact their physician or [health care provider] if they have experienced any problems that may be related to taking or using this drug product."

Sanofi is notifying retailers, consumers and distributors and arranging for return and reimbursement of the products, according to the release.

Consumers can contact cs@sanofi.com or 1-866-726-6340 with questions about the recall. Any adverse reactions or issues with the product can be reported to the FDA's MedWatch Adverse Event Reporting program.