Meridian Technologies has recalled 13 lots of Mylan Labs EpiPens and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
While the quantity of the recall is relatively small, at least for now, the severity surrounding the recall. The FDA noted that for those relying on the Epi Pen to treat a severe allergic reaction, product non-activation may lead to death.
At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.
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
Mylan drew heavy criticism from the public and the federal government last year for the exorbitant prices they were charging for their life critical EpiPens. In September 2016, Mylan had raised the cost of an EpiPen two-pack to $608, up from the around $100 the product cost when the company acquired the patent from Merck in 2007.
Reps. Jason Chaffetz (R-Utah) and Elijah Cummings (D-Md.), the top Republican and Democrat on the House Oversight Committee, sent a letter to the company’s CEO, Heather Bresch, seeking a non-public briefing.
“I would believe, knowing these committees, that [lawmakers] want them to come in, share information with them and then blast them at a committee hearing,” said a person with knowledge of congressional investigations who asked for anonymity to speak freely.
At this time, it is not known if the EpiPen recall will spread to other lot numbers or whether anyone suffered injuries as a result of the EpiPen defect.
Photo Credit by Intropin via WikiMedia Commons