Sanofi Auvi-Q Auto-injector Recall [US]


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US/Silver Spring: 6008 - SanofiAuviQAuto-injectorSanofi US recalls all Auvi-Q Auto-injectors (epinephrine injection, USP) due to possible inaccurate dosage delivery, injury and death hazards. FDA: http://ht.ly/U0x9S

Direct link: http://www.fda.gov/Safety/Recalls/ucm469980.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Auto-injectors are subject to this recall:

  • All Auvi-Q Auto-injectors (epinephrine injection, USP) currently on the market, including both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot number 2299596 through 3037230 which, depending on the specific package, expire from March 2016 through December 2016.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. An additional variation of the recalled Auvi-Q Auto-injector is pictured on the Web site above.

According to the FDA, as of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. None of these device malfunction reports has been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.

Customers should immediately contact their healthcare provider (“HCP”) for 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 9-1-1 or local medical emergency services. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product.

Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled Auto-injectors.

If you have questions regarding this recall can go to http://www.Auvi-Q.com or call 1-866-726-6340 Monday through Friday 8 AM to 8 PM Eastern Standard Time for information about how to return your Auvi-Q Injector. Customers may also send an e-mail to cs@sanofi.com. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.

==> To see important Safety Information relating to the safe administration of this drug, please consult the original recall notification as posted above.

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Additional information about this recall:
Recalls Direct RIN: 6008-2015
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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