BRIDGEWATER, N.J. (CN) - Sanofi US announced Thursday that it is voluntarily recalling all Auvi-Q epinephrine injections it sells to treat allergic reactions.
Sanofi warns that accurate dosages of Auvi-Q are necessary to treat allergic reactions since anaphylaxis is a potentially life-threatening condition.
"As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada," the company's recall notice states. "None of these device malfunction reports have been confirmed. In these reports, patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases."
Citing a possible "inaccurate dosage delivery," Sanofi said the recall involves "includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers."
Lot numbers 2299596 through 3037230, which expire March 2016 through December 2016, are affected.
"Auvi-Q is packaged with two active devices and one trainer device in a corrugate box," the drugmaker's statement says. "Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled."
Sanofi said it is notifying doctors, pharmacies, wholesalers and other customers in the supply chain about the recall by letter, fax, email and phone.
It is arranging for return and reimbursement of all recalled products.
"Customers should immediately contact their healthcare provider (HCP) for a prescription for an alternate epinephrine auto-injector," Sanofi said. "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. Customers should contact their physician or HCP if they have experienced any problems that may be related to taking or using this drug product."
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration, Sanofi said.
It noted that consumers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting.
"Sanofi US is committed to patient safety and the quality of Auvi-Q, and will continue to work closely with customers and regulatory authorities to resolve this issue in a timely manner," the company said in a statement.
Auvi-Q is meant to contain a single dose of epinephrine.
Sanofi notes that the product "should only be injected into your outer thigh," never into buttock or intravenously.
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