FDA issues alert about issue with EpiPens
November 06, 2018
Some EpiPen, EpiPen Jr. and authorized generic versions of the product may not easily slide out of their carrier tubes, which could block quick access to the device in an emergency, the U.S. Food & Drug Administration said Nov. 2.
Pfizer, the manufacturer of the EpiPen, said in a letter to health care professionals that a label sticker on the auto-injector was improperly applied in some cases, causing resistance when removing it from its carrier tube, according to the FDA. “In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube,” the FDA said, adding that the auto-injector and epinephrine it delivers are “not affected by this issue” and can still be used as prescribed.
The EpiPen injects a dose of epinephrine into a person’s thigh to stop an allergic reaction.
Pfizer’s letter asks patients to contact Mylan Customer Relations at 1-800-796-9526 if an auto-injector does not slide out easily from its tube or if the label is not fully adhered to the auto injector.
The FDA asks health care professionals and consumers to report adverse reactions or quality problems to the its MedWatch program online at www.fda.gov/medwatch/report.htm or by downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
Dentists can look for shortage notices, safety alerts and product recalls on the ADA Safety Alerts website by visiting ADA.org/SafetyAlerts.