Post by teddyw on Apr 1, 2017 0:30:57 GMT
They apparently don't inject the medicine.
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News Alerts > Medscape Medical News
Global EpiPen Recall Now Includes United States
Robert Lowes | Disclosures
March 31, 2017
The United States has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for anaphylactic shock on account of a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the US Food and Drug Administration (FDA) announced today.
Mylan, the company that markets the device, announced earlier this 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. The patients in question, however, were treated successfully with backup, functioning EpiPens.
Pressing the EpiPen into a person's thigh — the prescribed area for administration — 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.
The company announced today that it was expanding the recall not only to the United States, but also other markets in North America and South America.
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.
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
Source: FDA
For further assistance, EpiPen users can contact Mylan at 800-796-9526 or email customer service at customer.service@mylan.com.
EpiPens are made by Meridian Medical Technologies, a subsidiary of Pfizer.
More information about today's announcement is available at the FDA website.
To report any problems with EpiPen and EpiPen Jr. auto-injectors, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852
Medscape Logo
News Alerts > Medscape Medical News
Global EpiPen Recall Now Includes United States
Robert Lowes | Disclosures
March 31, 2017
The United States has joined the list of countries covered by a voluntary recall of EpiPen auto-injectors for anaphylactic shock on account of a defective part that may result in the device failing to inject a potentially life-saving dose of epinephrine, the US Food and Drug Administration (FDA) announced today.
Mylan, the company that markets the device, announced earlier this 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. The patients in question, however, were treated successfully with backup, functioning EpiPens.
Pressing the EpiPen into a person's thigh — the prescribed area for administration — 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.
The company announced today that it was expanding the recall not only to the United States, but also other markets in North America and South America.
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.
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
Source: FDA
For further assistance, EpiPen users can contact Mylan at 800-796-9526 or email customer service at customer.service@mylan.com.
EpiPens are made by Meridian Medical Technologies, a subsidiary of Pfizer.
More information about today's announcement is available at the FDA website.
To report any problems with EpiPen and EpiPen Jr. auto-injectors, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852
