The EpiPen 0.3 mg has an expiry date of May 2017 and lot number 5GU763.
EpiPens not included in the recall do not need to be replaced before their expiration dates, the FDA said.
Mylan, the manufacturer of EpiPen, issued a recall of over 80,000 EpiPens in countries including Norway, Denmark, Finland, Japan and Australia back in late March. Mylan brands adult versions with a yellow label and junior devices with a green label. Mylan's new generic EpiPen is not part of the voluntary recall and has been deemed a suitable replacement for the potentially defective product.
The defect, if present, would make an EpiPen have trouble activating, either requiring extra force or failing altogether, causing a delay in treatment of a severe allergic reaction.
EpiPens administer doses of epinephrine to patients with anaphylaxis - a serious allergic reaction that can be fatal if not treated immediately. The recalled products were manufactured and distributed between December 2015 and July 2016. The company said the action is being done with the knowledge of the U.S. The new recall not only covers EpiPens sold in the US, but also involves the children's version, known as EpiPen Jr.
List of recalled products from Mylan.
The FDA advises consumers to keep their devices until they have a replacement.