EpiPen®. Auvi-Q. Generic.
On March 31, 2017, Mylan announced that Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA). The recalled lot numbers include:
Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM087 October 2017
In the press release, Mylan indicated that they were committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Mylan is asking patients to keep their existing product until their replacement product can be secured. According to Mylan, patients may receive either Auto-Injector or the 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. Mylan stressed the importance that patients continue to carry their current EpiPen® Auto-Injector until they receive a replacement device.(https://www.epipen.com/recall-information)
Based on this information, we reviewed our Epipen expiration dates and learned that one of our four sets was recalled.
First, we went to our pharmacy that had our prescription on file and we were given the phone number (877-650-3494) to Stericycle. We called Stericycle to determine what to do with our recalled set of Epipens. After waiting for 45 minutes, our call was cut-off and then we were back in the queue for another hour and 15 minutes. Once we finally spoke to a person, they collected our personal information and indicated that someone from Stericycle would call us back with our voucher information. We thought this was odd and would be difficult to accomplish in a timely manner. Instead, on April 6th, we received our voucher information via email.
We then called our pharmacy to determine if we would be able to redeem the voucher. The pharmacist told us that the Mylan Epipens were back ordered and they did not know when they would be available but we could get the generic product. However, there was a catch on receiving the generic Impax Epinephrine Auto-Injector (EAI). We were informed by the pharmacist that we would need to obtain a new prescription for the generic. (http://www.epinephrineautoinject.com/)
As a result, we then contacted our allergist to determine what would be the best solution and if he would recommend the generic. In our case, the allergist did not recommend the generic as the administration of the epinephrine works differently, is not as user friendly and most importantly the needle does not retract after use. Instead of recommending the generic, they offered to connect us with Medvantx who could provide us with the Auvi-Q, which has been reintroduced into the market in 2017 after being recalled in 2015. After working with both our Allergist and Medvantx, we received our set of Auvi-Qs on May 4, 2017. In San Antonio at the 4th national FARE conference, we were trained on the Auvi-Q and we were very impressed. The product talks through the individual steps one at a time and makes this product very easy to use. Also, the computer will speed up the steps depending on how fast you move through them. Therefore, you don’t have to wait for the computer to catch-up. Also, the product is much smaller than the Epipens. The Auvi-Q is about the size of credit card with more thickness, about ½ inch. Our insurance did not cover this product, but the manufacturer ensured us that our out-of-pocket cost would be zero.
In addition to the Auvi-Q, our allergist provided us a new prescription so that we might be able to use our voucher at some point. Oddly, Mylan has asked us to keep our recalled product until we receive a replacement set of Epipens. We have received the packaging from Mylan to mail the recalled product back; however, we don’t plan to send back the recalled Epipens until we receive our replacement set. We are wondering when that will be… stay tuned for more to come on this.