A recall of the emergency anti-allergy medicine EpiPen is expanding to the U.S. and other markets in North America, Europe, Asia and South America because the allergy shots may not work.
The notice issued Friday by Mylan N.V. expands upon warnings made earlier this month after two reports of the device failing.
Mylan didn't immediately respond to a question about how many devices are affected by the recall. The U.S. Food and Drug Administration says the recall covers 13 lots distributed from December 2015 through July 2016.
The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare."
The EpiPen is used to treat allergic reactions to certain food and bug bites.
The products can be replaced at no charge by calling 877-650-3494 or emailing customer.service@mylan.com.
| 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 | April 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 |
