Information regarding the EpiPen recall

 

By David Showalter, PharmD, System Director, Pharmacy Services

 

In response to the recent EpiPen recall, Main Line Health’s pharmacy benefit manager, Optum, is sending information letters to MLH patients and providers. In addition, the following message was sent by Main Line Health to MLH employees:

 

On March 31, 2017, the FDA (Food & Drug Administration) issued a voluntary recall of certain lots of EpiPen and EpiPen Jr (epinephrine injection) auto-injector devices.  At this time, 13 lots have been identified (list below) that were distributed from the manufacturer (Mylan) between December 17, 2015 and July 1, 2016. The recall was issued after it was determined that these devices may contain a defective part that could result in device failure.

 

If you or your family member has an EpiPen or EpiPen Jr device, please check the lot number and expiration to determine if it is on the recall list. The lot and expiration date can be found in two locations: on the original carton that was dispensed from the pharmacy and on the device itself. Patients who have EpiPen devices from lots that are not included in this recall do not need to replace their EpiPen at this time.

 

For those patients who do have an EpiPen or EpiPen Jr with the affected lot numbers:

  • Patients should not return any devices affected by the recall until they have received their voucher to redeem their free replacement from their pharmacy. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.
  • Contact Stericycle at 1-877-650-3494. Stericycle is managing the recall for Mylan. Stericycle’s hours of operation are Monday-Friday 8 a.m.-10 p.m. ET, and Saturday and Sunday 8 a.m.-5 p.m. ET.
  • Stericycle will initiate the process of providing a container to return the recalled medication and will provide you with voucher information to acquire free replacement product
  • Patients may receive either EpiPen Auto-Injector or Mylan’s authorized generic for EpiPen Auto-Injector at the 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.

For additional information on the EpiPen and EpiPen Jr Auto-Injector product recall from the FDA, you can contact Mylan at 1-800-796-9526 or click on this link from the FDA: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm550170.htm

If you need additional help, you can also contact the Main Line Employee Pharmacy at 484-337-3600.

Product/Dosage Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 5GM640 May 2017
EpiPen Jr Auto-Injector, 0.15 mg 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 6GM087 October 2017

 

 

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