Updated April 3, 2017: Mylan announced on March 31 a recall in the United States of 13 lots of EpiPen epinephrine auto-injectors over the risk that a small number of the devices might fail to activate because of a manufacturing defect.
The lots of EpiPen and EpiPen Jr. that are affected were distributed between Dec. 17, 2015, and July 1, 2016. (Scroll to see chart; note that NDC numbers ending in “01” are also part of the recall.)
These are the only EpiPen lots impacted by the U.S. recall. Meridian Medical Technologies manufactures the devices, which Mylan Specialty distributes in the United States.
In a news release, Mylan said: “The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).”
The U.S. recall follows an earlier recall of certain EpiPen lots in Australia, New Zealand, Japan and Europe. That related to two devices – from one lot – failing to activate.
In Canada, distributor Pfizer Canada also recalled one lot of EpiPen Jr (5GR765) and one lot of the adult-strength EpiPen (5GU763), citing the same potential defect.
What to Do if Your EpiPens are on the Recall List?
In the USA: The Food and Drug Administration (FDA) advises consumers to keep and use their current EpiPens (if required) until they can get a replacement.
Consumers should contact the recall line at 877-650-3494 to receive a voucher code to give to your pharmacy in order to get replacement auto-injectors at no cost. The call lines are open Monday to Friday 8 a.m. to 10 p.m. EST and Saturday and Sunday 8 a.m. to 5 p.m. EST.
Mylan says: “Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability.” (The authorized generic is the equivalent to the brand name EpiPen.) For further information, see Mylan’s release here. If you have more questions, email Mylan at email@example.com.
In Canada: According to Pfizer Canada, pharmacies are replacing EpiPens listed on the recall list directly and for free. Simply take your auto-injector or injectors to your pharmacist. See the Canadian news release here.
Both North American distributors called the incidence of the defect “extremely rare.”
The FDA notes: “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.”
If You Suspect an Auto-Injector Device Malfunction:
• In an emergency, call 911.
• The FDA asks patients and doctors to report any suspected device malfunctions to the FDA’s MedWatch program here.