CCH advises on EpiPen® Auto-injector recall
Written by broebling on April 5, 2017
Press Release – Campbell County Health (CCH) has been advised of a worldwide voluntary recall of EpiPen® Auto-Injectors. This recall is being conducted as a result of possible failure to activate the device due to a potential defect in a supplier component. This could make the device difficult to activate in an emergency (failure or increased force needed to activate) and have significant health consequences.
EpiPens® contain epinephrine, which is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.
“We know that folks in our community use and rely on the EpiPen® and we feel it necessary to provide information when we become aware of recalls and other safety related issues,” said Robert Quintana, Campbell County Memorial Hospital Pharmacy Director.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the United States and also will extend to additional markets in Europe, Asia, North and South America. The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. The U.S. impacted lots are provided in the table below.
Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. They are asking patients to keep their existing product until their replacement product can be secured.
Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at their primary pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.
To return product please contact Stericycle at 877-650-3494. For additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or email@example.com.
|Product/Dosage||NDC Number||Lot Number||Expiration Date|
|EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg||49502-501-02||5GN767||April 2017|
|EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg||49502-501-02||5GN773||April 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||5GM631||April 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||5GM640||May 2017|
|EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg||49502-501-02||6GN215||September 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM082||September 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM072||September 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM081||September 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM088||October 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM199||October 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM091||October 2017|
|EpiPen 2-Pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM198||October 2017|
|EpiPen 2-pak® Auto-Injectors, 0.3 mg||49502-500-02||6GM087||October 2017|