Sanofi said Friday that the recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. The products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug, according to the company.
The product recall, being made with the knowledge of the Food and Drug Administration, includes lot numbers 2081278 through 3037230, which expire October 2015 through December 2016, Sanofi said.
If a patient didn’t receive the intended dose, there could be serious health consequences, including death because anaphylaxis is a potentially life-threatening condition, Sanofi noted.
The company said that as of Oct. 26, it has received 26 reports of suspected device malfunctions in the United States and Canada (where the product also has been recalled and is sold under the name Allerject). Though none of these device malfunction reports have been confirmed, in the reports patients have described symptoms of the underlying hypersensitivity reaction. No fatal outcomes have been reported among these cases.
Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. The product was distributed in the United States via wholesalers, pharmacies and hospitals. Sanofi US said it’s 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 products.
The company said that for consumers it also will provide reimbursement for out-of-pocket costs incurred for the purchase of new epinephrine auto-injectors with proof of purchase.