Global EpiPen Recall Now Includes United States

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 https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Article originally posted here: Global EpiPen Recall

Why See an Allergist for Asthma?

Asthma is a chronic condition affecting the lungs, causing shortness of breath, wheezing, and chest tightness. It is an inflammatory disorder of the lungs and most forms of asthma have an important, underlying allergic component. Those with asthma often have “triggers” that lead to attacks or asthma symptoms; triggers may include mold, pollen, dust particles, pet dander, respiratory illness, air pollution (including smoke), and exercise.

Allergists are asthma specialists and have undergone rigorous training in its management. Principle to asthma management is identifying triggers, clarifying the diagnosis, addressing co-existing conditions interfering with asthma control and building the proper treatment plan. An allergist can test for allergic triggers and educate patients in managing allergic (and non-allergic) triggers, as well as provide regular care and follow-up for those suffering from asthma.

Allergen immunotherapy (allergy shots) can be a very useful treatment component for asthmatics, and allergists are specifically trained in the proper prescription and administration of allergy shots. There is also evidence that allergy shots can prevent the development of asthma in children.

Additional studies have shown that asthmatic patients who receive care by an allergist have reduced emergency room visits, reduced rates of hospitalization, decreased asthma symptoms and overall improvement in their asthma-related quality of life.

An allergist is a great resource for anyone who experiences asthma symptoms. Government guidelines from the National Heart, Lung and Blood Institute (NHLBI)recommend seeing an asthma specialist, such as an allergist, if you:

  • Have asthma symptoms every day and often at night that cause you to limit your activity
  • Have had a life-threatening asthma attack
  • Do not meet the goals of your asthma treatment after three to six months
  • Are not responding to current treatment
  • Have symptoms that are unusual or hard to diagnose
  • Have conditions such as severe hay fever or sinusitis that complicate your asthma or your diagnosis
  • Need more tests to find out more about your asthma and what causes your symptoms
  • Need more help and instruction on your treatment plan, medicines or asthma triggers
  • Might benefit from allergy shots
  • Need treatment with oral or injectable steroids
  • Have stayed in a hospital because of your asthma
  • Need help identifying your asthma triggers
  • Have a child with frequent or troubling asthma symptoms

At The Allergy and Asthma Medical Group our experienced allergists can help monitor your asthma symptoms, and keep the disease under control. We are able to perform pulmonary function testing in our office, and also are equipped to treat acute asthma attacks. While asthma cannot be cured, with the proper care and guidance it can be completely manageable.

The Allergy and Asthma Medical Group of the Bay Area has office locations in Walnut Creek, San Ramon, Brentwood, Pleasanton and Berkeley. Our Board Certified Allergists treat both adults and children. We offer extended office hours to accommodate patients with busy schedules.

The Hypoallergenic Dog – Wishful Thinking?

A dog allergy can be a heart-breaking condition for the pup-loving individual. It is understandable that in a country where nearly 40% of households include a dog the idea of a hypoallergenic dog has become so popular. Unfortunately, while certain dogs may cause fewer allergy symptoms than others, there is no such thing as a hypoallergenic dog breed. In fact, one dog and another of the same breed can produce very different levels of allergen.

There is a wide misconception that pet allergies are caused by a dog or cat’s fur, but in fact it is the pet’s dander – secretions from glands in the skin – that causes the allergy symptoms. Proteins found in a dog’s saliva, urine and skin become dander with shed skin cells, these flakes are the real source of the allergen. So no matter if the dog has hair or fur, short or long, any dog can potentially cause an allergic reaction.

Some dog breeds, such as poodles, Portuguese water dogs, or mixed breeds such as the goldendoodle, are marketed as hypoallergenic dogs because they do not shed fur or they shed very little. Because these dogs do not shed, the allergy-causing dander that sticks to their fur is not as easily released into the air or onto the floor as much as it would with a shedding dog. Sufferers may experience fewer allergy symptoms with a non-shedding dog, but no dog breed is truly hypoallergenic.

The Allergy and Asthma Medical Group of the Bay Area has office locations in Walnut Creek, San Ramon, Brentwood, Pleasanton and Berkeley. Our Board Certified Allergists treat both adults and children. We offer extended office hours to accommodate patients with busy schedules.