Global EpiPen Recall Now Includes U.S.

April 1, 2017 -- The U.S. has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for severe allergic reactions.

The recall was triggered by a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the FDA said Friday.

Mylan, the company that markets the device, announced last month that it was recalling one lot of roughly 80,000 EpiPens in Australia, Europe, Japan, and New Zealand. It reported two instances of the device failing to deliver its dose, although the two people were able to use backup EpiPens. Pressing the EpiPen into a person's thigh — where the pen is designed for use — causes a needle to penetrate skin and inject epinephrine into muscle. The defective part may require a person to use increased force to activate the needle, or it may prevent the EpiPen from working at all, according to Mylan.

In the United States, the recall applies to 13 lots of both EpiPen and EpiPen Jr. auto-injectors distributed between December 17, 2015, and July 1, 2016. Patients can receive another EpiPen or an authorized generic version at their pharmacy, Mylan said. In the meantime, they should continue to carry and use their current EpiPen until they acquire a replacement.

The affected lots are:

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 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

 

For further assistance, EpiPen users can contact Mylan at 800-796-9526 or email customer service at customer.service@mylan.com.

More information about the recall is available at the FDA website.

Medscape Medical News

Sources

SOURCES:

News release, FDA

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