Epinephrine 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. Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has announced a voluntary recall for select lots of EpiPen® (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors. The recalled lot numbers are below and were distributed from December 15, 2015, through July 1, 2016.
Additional Information:
Product: EpiPen® (epinephrine injection, USP) Auto-Injectors and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors
- Dosage: EpiPen® is 0.15 MG; EpiPen Jr® is 0.3 mg
- Indication: treatment for a life-threatening allergic reaction (anaphylaxis)
- Manufacturer: Meridian Medical Technologies
- Lots impacted for EpiPen®:
- Lot: 5GN767/Expiry: April 2017
- Lot: 5GN773/Expiry: April 2017
- Lot: 6GN215/Expiry: Sep. 2017
- Lots impacted for EpiPen Jr®:
- Lot: 5GM640/ Expiry: May 2017
- Lot: 6GM081/ Expiry: September 2017
- Lot: 6GM198/ Expiry: October 2017
- Lot: 5GM631/ Expiry: April 2017
- Lot: 6GM088/ Expiry: October 2017
- Lot: 6GM087/ Expiry: October 2017
- Lot: 6GM082/ Expiry: September 2017
- Lot: 6GM199/ Expiry: October 2017
- Lot: 6GM072/ Expiration Date: September 2017
- Lot: 6GM091/ Expiration Date: October 2017
- Type of recall: Voluntary
- Reason for Recall: due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate.
- Return/Replacement information: Patients with unused EpiPen or EpiPen Jr. Auto-Injector product bearing the recalled lot number should contact Stericycle at 877-650-3494, Monday through Friday 8 a.m. – 10 p.m. ET, or Saturday and Sunday 8 a.m.-5 p.m. ET. Stericycle will provide a voucher number to cover the cost for replacing each 2 pak of recalled product. Stericycle will also facilitate the return of the recalled product for Mylan.