EpiPen Auto-Injector Recalled
On March 31, 2017 Mylan expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors in consultation with the U.S. Food and Drug Administration (FDA). This recall is being conducted because of two reports, outside of the U.S., indicating a failure to activate the device due to a potential defect in a supplier component.
This potential defect could make activating the auto-injector difficult and cause significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Failure of the auto-injector to function is rare and testing across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded as a precautionary measure.
It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a voucher and obtain a free replacement.
Patients must contact Stericycle at 877-650-3494 to begin the process for replacement of a recalled product. Once Stericycle confirms the product has been recalled they will provide a voucher for a replacement. For any medication not part of a recalled lot there is no further action required.
Additional questions regarding this recall can be directed to Mylan Customer Relations at 800-796-9526 or email@example.com.
The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. The recall does not include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016.
Patients can also refer to Mylan.com/EpiPenRecall for additional information about the recalled lots as well as product return and replacement instructions.
The U.S. Food and Drug Administration (FDA) has approved the first AB-rated generics to Lilly’s Strattera® (atomoxetine), a drug approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Generic exclusivity was not granted. Generics were approved from Apotex, Aurobindo, Glenmark and Teva.
Strattera is a non-stimulant drug originally approved by the FDA in 2002. The last patent for Strattera expired on May 26, 2017. As a result, the FDA was able to approve all eligible atomoxetine abbreviated new drug applications (ANDAs).
Shipments of the generics have already begun.