EpiPen Recall 2017: Full List of Mylan Products - How to Get Replacements
Pharmaceutical company Mylan has expanded the recall of EpiPen auto-injectors in the United States, as well as in North America, Europe, Asia and South America. The epinephrine injectors are being pulled out from the market over concerns of defective EpiPen devices failing to work in life-and-death situations. How do consumers check and turn in their EpiPens for replacement?
The United States Food and Drug Administration (FDA) has released a bulletin about the EpiPen recall. The devices covered by the voluntary recall come from 13 lots of EpiPen and EpiPen Jr. auto-injectors that were manufactured by Meridian Medical Technologies and distributed by Mylan, according to the FDA's press announcement.
EpiPen devices are used as emergency allergy shots in the United States and other countries in cases of severe allergic reactions to food or bug bites. The devices are being recalled following reports of two emergency cases in which the device failed to work, according to CNBC.
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See below the full list of EpiPen batches that are subject to the recall, courtesy of the FDA.
| 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 |
The lot number and expiry date can be found on the box similar to the image shown here. An important note from Mylan on looking up NDC numbers: "The NDC on the box ends with '2' because it contains two EpiPen Auto-injectors. The NDC on the individual EpiPen within the box has an NDC ending in '1.'"
Consumers with EpiPens covered by the recall should contact Stericycle at 877-650-3494 to get their replacement injectors.
FDA's bulletin advises consumers who own affected injectors that they "should keep and use their current EpiPens if needed until they get a replacement," according to the announcement.
According to the FDA bulletin, EpiPen lots that are not included in the recall do not need to have their devices replaced, as long as the product has not yet expired. Mylan has also set up a webpage dedicated to the recall, and step-by-step instructions for getting replacement EpiPens can be found on their EpiPen Recall page.
Mylan has said that the company has recalled about 81,000 EpiPen devices outside the United States since the reported incidents. The recall is the latest of the company's problems, having been the focus of federal investigations and criticism over the price premium that the company has been adding to the life-saving device.
