On September 5, 2017, FDA issued a warning letter to a Meridian Medical Technologies facility, located in Brentwood, Missouri, which manufactures Mylan’s EpiPen (epinephrine injection). The warning letter identifies significant violations of current good manufacturing practice (CGMP) requirements for its epinephrine auto injectors, including EpiPen and EpiPen Jr, and instructs the company to undertake steps to correct those violations. FDA understands the importance of epinephrine auto-injectors and will work to ensure that the company’s corrections are adequate so that patients can be assured of the safety and efficacy of the products.
FDA is not aware of defective EpiPens currently on the market and recommends that consumers use their prescribed epinephrine auto injector. As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens.
FDA asks health care professionals and consumers to report any adverse reactions or quality problems to the FDA’s MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm.
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.