EpiPen and EpiPen Jr. auto-injectors are being voluntarily recalled in the United States over fear a defective part will prevent the auto-injectors from working properly. EpiPen (epinephrine injection, USP) and EpiPen Jr. (epinephrine injection, USP) administer epinephrine to counteract serious allergic reactions including anaphylaxis. Mylan and its manufacturing partner for EpiPen auto-injectors, Meridian Medical Technologies (“Meridian”), are voluntarily recalling 13 lots of both its EpiPen and EpiPen Jr. auto-injectors over the potential failure of a key component part.
The voluntary recall is done in conjunction with the U. S. Food and Drug Administration (“FDA”) and was initiated after two reports of failure of the activator to work in the EpiPen. Both incidents were reported and occurred outside the U. S.
The affected devices were distributed between December 17, 2015 and July 1, 2016, and include both the 0.3 mg and 0.15 strengths of EpiPen auto-injectors. The generic version of the EpiPen auto-injector, incidentally also manufactured by Meridian, is NOT affected by the recall.
The affected U. S. lots include:
|Product/Dosage||NDC Number||Lot Number||Expiration Date|
|EpiPen Jr Auto-Injector, 0.15 mg||49502-501-02||5GN767||April 2017|
|EpiPen Jr Auto-Injector, 0.15 mg||49502-501-02||5GN773||April 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||5GM631||April 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||5GM640||May 2017|
|EpiPen Jr Auto-Injector, 0.15 mg||49502-501-02||6GN215||September 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM082||September 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM072||September 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM081||September 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM088||October 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM199||October 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM091||October 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM198||October 2017|
|EpiPen Auto-Injector, 0.3 mg||49502-500-02||6GM087||October 2017|
To determine if your auto-injector is affected, locate the lot number, which can be found in two places: on the outside opening of the EpiPen carton, and on the auto-injector itself.
Mylan recommends patients continue to carry their EpiPens and EpiPen Jr. auto-injectors until a replacement device is secured.
If your EpiPen or EpiPen Jr. auto-injector is affected, call Stericycle at 877-650-3494 for a voucher code to obtain a replacement EpiPen or EpiPen Jr. device. You will receive a pre-paid return package to ship your recalled EpiPens back to Stericycle.
Replacements devices are free to patients. Once you receive your voucher code from Stericycle, take it to your pharmacy to receive your replacement device, or an authorized generic device. Mylan advises the authorized generic “is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.”
Additional questions may be directed to Mylan Customer Relations at 800-796-9526 or firstname.lastname@example.org.
If you experience any adverse reactions or have problems with using your EpiPen device, or any medical device or product, please report those problems to the FDA’s MedWatch Adverse Event Reporting program. You can file an Adverse Event report at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or by calling 800-332-1088 to request an Adverse Event reporting form.