Medicine recalls
|
| |
| The United States: Sanofi US issues voluntary nationwide recall of Auvi-Q due to potential inaccurate dosage delivery |
| |
Bridgewater, N.J. - Sanofi US is voluntarily recalling all Auvi-Q (epinephrine injection, USP). 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. This includes lot number 2299596 through 3037230, which expire March 2016 through December 2016. The products have been found to potentially have inaccurate dosage delivery.
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 because 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. 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.
Auvi-Q is used to treat life-threatening allergic reactions (anaphylaxis) in people who are at risk for or have a history of these reactions. Auvi-Q is packaged with two active devices and one trainer device in a corrugate box. Auvi-Q was distributed throughout the United States via wholesalers, pharmacies and hospitals. All Auvi-Q is being recalled.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm469980.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news on the same product marketed under a different brandname of Allerject has been issued by Health Canada, and was posted on the Drug Office website on 29 October 2015.
Ends/ Friday, October 30, 2015
Issued at HKT 16:00
|
| |
