Mylan issued a worldwide recall for both of their EpiPen and EpiPen Jr. Auto-Injectors on March 31, 2017. This is an amendment to the original U.S.-only notice and now includes North and South America, Asia, and Europe. The announcement was made as a result of two separate reports from outside the United States.
The recall is for the 0.3 mg and 0.15 mg strengths.
Physicians prescribe this medication to prevent an allergic reaction from becoming a dangerous event. While complying with this notice is voluntary, one should consider the impact of attempting to use a faulty epinephrine injection when there is the possibility of anaphylaxis.
The company stresses the importance of continuing to carry one’s current EpiPen or EpiPen Jr. Auto-Injector until a replacement is obtained.
Recall Details for EpiPen
EpiPen Auto-Injectors in question were manufactured by Meridian Medical Technologies, which is a subsidiary of Pfizer. Recalled EpiPens were distributed by Mylan Specialty between December 2015 and July 2016. None of the lots in the recall include the licensed generic medication, also from Meridian.
The reported failure to active is the result of a potential flaw in a component, manufactured by an outside supplier. The device might fail to activate or cause the user to apply excessive force.
Mylan reports the failed devices were from a previously recalled lot. The press release states,
The incidence of the defect is extremely rare, and, testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of abundance of caution.
Mylan Commits Replacement of Recalled EpiPen Injectors
The drug distributor wants those affected by the recall to know they will incur no cost for replacement. Replacements will be either an EpiPen Auto-Injector or the licensed generic at the patient’s pharmacy as available.
Both the brand and the generic have the same drug formulation. Additionally, the generic pen operates the same as the EpiPen with therapeutic equivalence. One may be substituted for the other.
If a patient experiences a negative reaction or quality problems with the EpiPen, they may contact the FDA MedWatch Adverse Event Reporting program. Consumers may file the report by regular mail, fax or online.
The forms may be downloaded or filed using the Report a Problem feature. Also, on the page, a person can sign up for updates.
Mylan is notifying their patients, customers, and distributors. For further update return and replacement instructions, use this web address: Mylan.com/EpiPenRecall.
To return an EpiPen Auto-Injector consumers should phone Stericycle at 877-650-3494. If there are further questions concerning the recall, Mylan Customer Service may be contacted at 800-796-9526 or firstname.lastname@example.org.
Finally, EpiPens and the generic equivalent are the first defense to anaphylaxis, a life-threatening condition brought on by a severe allergic reaction. Any delay in the administration of epinephrine is related to adverse health consequences. It is of vital importance that patients continue to carry and use the current EpiPen until a replacement is obtained.
By Cathy Milne
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FDA – U.S. Food and Drug Administration: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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