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Health Announcements

March 31, 2017

FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement.

Consumers should contact Stericycle at 877-650-3494 to return the product.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

 

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

 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or 

Downloading and completing the form, then submitting it via fax at 800-FDA-0178.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm 

 

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In 1973, Section 504 of the Rehabilitation Act was enacted by Congress while ensures civil rights protections to individuals with disabilities.  Recent court rulings and Office of Civil Rights guidance documents indicate that students who have individual health plans or have been diagnosed with diseases such as diabetes, Crohn’s disease, cystic fibrosis, irritable bowel syndrome, epilepsy, etc. may qualify for Section 504 protections.

If you would like your child to be evaluated for possible Section 504 eligibility, please contact Laurie Gordon, 409-883-6970 or Kelly Meadows, RN, (409) 886-4245 ext 5.

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Hours for the UTMB Immunization Clinic:  Monday - Friday, 8a-5p; appointments beginning at 8:30a.  Please call for an appointment prior to going to the clinic.  In order to receive school shots, you must bring your shot record and a letter from the school, indicating the shot(s) needed by student.  For more information about who qualifies for services and costs of services, please call the immunization clinic at 409-883-6119.

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Attention 6th grade students/Parents:   6th graders will need 3 immunizations to begin their 7th grade year. You can get these now to avoid the summer rush.  The immunizations are Meningoccal (meningitis), Tdap (tetanus), and Varicella (chicken pox). For questions, contact your school nurse.

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The School Health Advisory Council (SHAC) needs members!  If you are interested in the health and health education of students and would like to be a part of this district committee, please contact any of the campus nurses or Kelly Meadows, RN, 409-886-4245, ext 5.
 

Kelly Meadows

Upcoming Events

Contact Kelly Meadows

School Phone:
(409) 886-4245 ext 5