(RxWiki News) The US Food and Drug Administration (FDA) has released information on a recall of certain lots of EpiPen and EpiPen Jr Auto-Injectors.
These medications, which are used to treat life-threatening allergic reactions, are being recalled because they reportedly failed to activate.
Two reports outside the United States said the devices failed to activate, according to the FDA. During an emergency, this issue could be serious.
Mylan and Meridian Medical Technologies issued this recall for 13 lots of the devices manufactured and distributed between December of 2015 and July of 2016:
The lots affected by this recall include the following:
- EpiPen Jr Auto-Injector, 0.15 mg; NDC #: 49502-501-02
- Lot #: 5GN767; Expiration Date: April 2017
- Lot #: 5GN773; Expiration Date: April 2017
- Lot #: 6GN215; Expiration Date: September 2017
- EpiPen Auto-Injector, 0.3 mg; NDC #:49502-500-02
- Lot #: 5GM631; Expiration Date: April 2017
- Lot #: 5GM640; Expiration Date: May 2017
- EpiPen Auto-Injector, 0.3 mg; NDC #: 49502-500-02
- Lot #: 6GM082; Expiration Date: September 2017
- Lot #: 6GM072; Expiration Date: September 2017
- Lot #: 6GM081; Expiration Date: September 2017
- Lot #: 6GM088; Expiration Date: October 2017
- Lot #: 6GM199; Expiration Date: October 2017
- Lot #: 6GM091; Expiration Date: October 2017
- Lot #: 6GM198; Expiration Date: October 2017
- Lot #: 6GM087; Expiration Date: October 2017
The FDA said patients and their caregivers should refer to www.Mylan.com/EpiPenRecall for updates, particularly on product return and replacement instructions. The FDA also recommended keeping the current device until a replacement is secured.
Consumers should report device malfunctions and adverse reactions to the FDA's MedWatch program, the FDA recommended.
The medication information says EpiPen users should seek immediate emergency medical attention after using the device — especially if the device did not activate.
If you have any questions about your medication, ask your doctor or pharmacist.
