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

For Immediate Release

March 31, 2017

Release

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recalldisclaimer icon 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 Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

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:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 
 
 UB S‐miles To Go Dental Program Coming To Pine Valley Again This Year!    
 
Arrangements have been made to have the University at Buffalo (UB) Mobile Dental Unit come to Pine Valley April 30 – May 2 (these dates are subject to change).  Pre‐screening will take place in the nurses’ offices March 6th‐ 10th.  UB’s School of Dental Medicine has served the oral health care needs of children for 15 years with its school‐based mobile dental unit.  This state‐of‐the‐art unit features a wheelchair lift, a panoramic X‐ray unit, digital radiography, an intake/ education area and electronic patient records. The program is managed by pediatric and general dentists, dental hygienist, UB dental students and dental assistants. Students need to sign up annually for this service. Registration forms are available on line or from the school nurses.    The S‐MILES TO GO DENTAL PROGRAM offers the following dental services for students Pre‐K through grade 12:  A new three‐chair mobile dental office that will be parked at the school;  Examinations, x‐rays, cleanings, fillings and other dental services;  Low fees for patients without insurance; information on financial assistance will be available through the UB Dental CARES Program.    Acceptance of Medicaid, Family Health and Child Health Plus Insurance Programs;  
 
 
Needle Attention Parents:
New for the 2017-2018 School Year
 
All kids entering 7th and 12th grade must have the meningococcal vaccine.
Without it they can't start school 

 

 
 
 
 
 
Caution Sign Ventolin Recall
 
GlaxoSmithKline (GSK) has recalled some of their Ventolin HFA Inhalers. Please check inhalers for the recalled lot numbers listed below. Follow the GSK recall directions if needed.
Product Description: Ventolin HFA (albuterol Sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral inhalation Only.
 
Recall Number: D-0519-2016
Code Information: Lot Numbers: 5ZP1708, Exp. 12/2016; 5ZP1951, Exp. 02/2017
 
 
 

Recall Test Strips due to Inaccurate Blood Sugar Readings

 

Arkray is recalling the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because:

 

·         They may report falsely low blood glucose levels

·         There is a risk that Hyperglycemia, Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome may go undiagnosed

 

Affected products include:

 

·         Lot Numbers: PN5C26 $ EA4M78

·         Manufacturing Dates: November 2014 to September 2015

·         Distribution Dates: February 18, 2015 to October 13, 2015

·         25 foiled packaged test strips per box

 

Recommendations:

·         Return unused product 

·         A Replacement product will be shipped free of charge

·         Report adverse events  to the FDA's MedWatch

·         Complete and submit the report Online:

 

 

Read the MedWatch safety alert @ www.fda.gov/MedWatch/report 
 
 
Syringe
Attention Parents/Guardians: New Immunization Requirements for September 2015

 

The Department’s Immunization Guidelines for Schools have been revised to reflect these changes. We would like to take this opportunity to highlight changes below:

Students entering K, 1st, 6th, and 7th grades in the 2015-16 school year will now be required to have 2 doses of the varicella (chicken pox) vaccine and 3-4 doses of poliomyelitis vaccine. All other students will be able to attend school this year with 1 dose of varicella, and 3 doses of poliomyelitis.

Students will now need 2 doses of measles, and mumps, and 1 dose of rubella vaccine in K through 12th grade. Students will no longer be able to wait until age7 to meet this requirement.

Students entering 8th through 12th grade (or comparable age level grade equivalents) in the 2015-16 school year shall be deemed in compliance with the immunization requirements until the last grade of this cohort graduate from school in 2020, if they had satisfied the immunization requirements in effect in regulation on June 30, 2014. This cohort does not need the immunization intervals assessed.

  There are also new regulations excluding students from school for immunization-compliance and for medical exemptions.
  Mrs. Pollock or Mrs. Kenney will only send letters home to parents whose child’s immunizations need to be updated. The letter will include specific immunizations that need to be taken care of before the 1st day of school or your child will be excluded(not allowed to come) from school. Please call Mrs. Pollock(Elementary) at 988-3291 ext. # 3325 or Mrs. Kenney (High School) at 988-3276 ext. # 4324 if you have any questions.   
 

 Cat Doctor doing Exanm on Cat Student All 7th and 10th grader students need to have physical exams per state mandates. Physicals will be scheduled with Dr. Tat-Sum Lee, school physician, during the school year. If your son/daughter had a physical this summer or you don't want the physical done at the school, there are forms in the main office to be completed by your family physician.  This also applies to all new students, but they only have thirty days to get a physical.
 


Spinning Medication Bottle Medication Regulations During School All Students wishing/or needing to have medication during school hours need to follow the existing State Law and The Regulations Of The Commissioner Of Education. See Attached requirements for medication.  Note: This includes a physician order and parent permission sheet. Students must supply their own medication and it must be brought in by a parent.
 

File drawer All Forms Can Be Found On The District Health Office Forms Page On The Left Column.
 
Last Modified on April 3, 2017
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