(CNN/RNN) - Parents whose children use EpiPens should take note: a widespread shortage across the country could send kids who have serious allergies back to school unprotected.
The EpiPen shortage, which has been an issue for months, has been caused by manufacturing issues and local supply disruptions.
Sales of EpiPen devices typically spike during the back-to-school season.
The EpiPen is the most-widely prescribed epinephrine auto-injector in the U.S., the Food and Drug Administration said. It is used to treat anaphylaxis episodes, a medical emergency that affects the whole body and, in some cases, leads to death.
Nearly one in 50 people in the U.S. have had anaphylaxis episodes, and nearly 6 million children in the U.S. have food allergies.
It's not clear how many children could be affected, and the shortage can vary among pharmacies.
Patients are encouraged to call Mylan's customer relations line at 800-796-9526 for assistance in locating the product, the company noted.
The FDA approved the first generic version of EpiPen on Thursday, and the FDA's chief alluded to the shortages in his statement.
"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb said.
Since buying the rights to the drug in 2007, Mylan has raised the price from less than $100 to more than $600 for a set of two injections, the New York Times reported.
A generic version sells for $300, the LA Times said.