FDA alerts patients, professionals that some EpiPen auto-injectors may not easily slide from carrier tube
Click Here to Manage Email Alerts
The FDA announced that due to improper attachment of labels, some EpiPen 0.3-mg and EpiPen Jr 0.15-mg auto-injectors may be unable to dispense epinephrine.
The FDA was alerted to the issue by a letter from the EpiPen manufacturer (Pfizer), which warned that because of the label blockage, the carrier tube in some devices may become stuck.
According to Pfizer, there is a 0.007% chance of this issue affecting any device and the potential blockage does not affect the actual auto-injector device or the epinephrine itself.
The FDA said it has not received any reports of adverse events related to this issue but advises careful inspection of these products by health care professionals and patients alike.
A shortage of EpiPens has been reported in the U.S. this year, although other alternatives exist.
Reference: