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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 650 physicians and allied health professionals practice at 35 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, 23 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 seven 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 a Patient-Centered Medical Home. Kelsey-Seybold has many physicians in the Greater Houston area certified for excellence in diabetes and heart and stroke care by the NCQA. In addition to these recognitions, Kelsey-Seybold is home to a nationally accredited Breast Diagnostic Center and Endoscopy Center.
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