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Recall Announced for Mylan’s EpiPen and EpiPen Jr

Alert issued by the U.S. Food and Drug Administration

Houston (March 29, 2017) - On March 31, 2017 the U.S. Food and Drug Administration issued an alert notifying consumers that 13 lots of Mylan’s EpiPen and EpiPen Jr Auto-Injectors are being voluntarily recalled. The recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate.

While the number of reported failures is small, EpiPen and EpiPen Jr products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated.

Consumers should check the list below and if the lot number and expiration on their EpiPen or EpiPen Jr are listed, they should get a replacement. Consumers should keep and use their current EpiPen or EpiPen Jr if needed until they get a replacement. Replacement is necessary only if the EpiPen or EpiPen Jr lot number and corresponding expiration date are listed below.  This recall applies only to the branded product. It does not apply to the authorized generic version of EpiPen or EpiPen Jr.

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 Jr Auto-Injector, 0.3 mg  49502-500-02  5GM631  April 2017
 EpiPen Jr 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 Jr Auto-Injector, 0.3 mg  49502-500-02  6GM082  September 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM072  September 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM081  September 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM088  October 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM199  October 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GMM091  October 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM198  October 2017
 EpiPen Jr Auto-Injector, 0.3 mg  49502-500-02  6GM087  October 2017

After confirming that you have the recalled EpiPen or EpiPen Jr, Mylan is ask asking consumers to first contact Stericycle at 877-650-3494. Stericycle’s hours of operation are Monday-Friday 7 a.m. to 9 p.m. CST and Saturday and Sunday 7 a.m. to 5 p.m. CST. Stericycle will initiate the process of providing a container to return the recalled medication. Consumers should not return any affected devices until they have received a voucher to redeem their free replacement from their pharmacy.

If you do not find your lot number and corresponding expiration date on this list, your EpiPen or EpiPen Jr is not affected by the recall and there is no further action necessary.  

Kelsey Pharmacy patients who have questions about this recall can speak with a Pharmacy team member by calling: 713-442-5250. Patients who need help in identifying whether their EpiPen or EpiPen Jr is part of the recall can bring their injector to their nearest Kelsey Pharmacy where a Pharmacy team member can help identify affected product. Patients who have received a voucher for a replacement EpiPen or EpiPen Jr are encouraged to visit their local Kelsey Pharmacy at their earliest convenience to help ensure they have the life-saving medicine they need to protect from a severe allergic reaction.

About Kelsey-Seybold

Kelsey-Seybold Clinic is Houston's premier multispecialty group practice, founded in 1949 by Dr. Mavis Kelsey in Houston's renowned Texas Medical Center. More than 850 physicians and allied health professionals practice at 40 locations in the Greater Houston area. Kelsey-Seybold offers quality medical care in 65+ medical specialties. The organization operates the largest freestanding Ambulatory Surgery Center in the state of Texas and offers state-of-the-art Varian TrueBeam and Varian Edge radiation therapy technology at a nationally accredited Cancer Center. An accredited Sleep Center, comprehensive laboratory services, advanced imaging and diagnostics, 24 onsite Kelsey pharmacies and one specialty pharmacy, and MyKelseyOnline, a secure web portal, are part of its comprehensive offerings. Kelsey-Seybold partners with major insurers to offer value-based commercial health plans. KelseyCare Advantage, a Medicare Advantage plan offered to Houston-area beneficiaries and affiliated with Kelsey-Seybold Clinic, has achieved the coveted 5-out-of-5-star rating from the Centers for Medicare and Medicaid for eight consecutive years.

Kelsey-Seybold has been recognized by the National Committee for Quality Assurance (NCQA) as the nation’s first accredited Accountable Care Organization and is home to a nationally accredited Breast Diagnostic Center and Endoscopy Center.

Kelsey-Seybold Clinic achieved a Net Promoter Score (NPS) of 91. NPS is the global standard for measuring customer loyalty and satisfaction. An NPS score of 70 or higher is considered by industry experts to be "world class" and an indicator of overwhelming customer loyalty.

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