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DG Peds Blog
HERTFORDSHIRE, England and PITTSBURGH, March 31, 2017 -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).
This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.
The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.
U.S. Impacted Lots:
|
Product/Dosage |
NDC Number |
Lot Number |
Expiration Date |
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg |
49502-501-02 |
5GN767 |
April 2017 |
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg |
49502-501-02 |
5GN773 |
April 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
5GM631 |
April 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
5GM640 |
May 2017 |
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg |
49502-501-02 |
6GN215 |
September 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM082 |
September 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM072 |
September 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM081 |
September 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM088 |
October 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM199 |
October 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM091 |
October 2017 |
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM198 |
October 2017 |
|
EpiPen 2-pak® Auto-Injectors, 0.3 mg |
49502-500-02 |
6GM087 |
October 2017 |
Product Replacement Instructions:
Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.
Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.
It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.
To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or [email protected].
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This voluntary recall is being conducted with the knowledge of FDA.
Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.
More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.
Please see the full Prescribing Information and Patient Information.
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Be a Flu Fighter! Get your flu shot today!
Flu shot clinic hours are available at both the Downers Grove and Bolingbrook offices. Call for an appointment today.
A big THANK YOU to one of our kind parents for the generous donation of books to our Reach Out and Read program. These books will be given out to kids at their well child visits to promote reading. DG Peds is proud to continue our Reach Out and Read program now going into our 16th year. THANK YOU!
Here is a link to learn more about Reach Out and Read.
From the American Academy of Pediatrics and healthychildren.org,
March is ‪#NationalNutritionMonth. Good nutrition=good health! http://ow.ly/XRMxZ
The specific nutritional choices you and your youngster make are crucial. Good nutrition is essential to good health and the American Academy of Pediatrics encourages parents to think of their nutritional decisions as health decisions.
healthychildren.org
Join us for Read Aloud Month and help every parent understand how reading aloud 15 minutes every day from birth through 3rd grade builds a child's brain and lifelong learning capacity. ‪#readaloud
Downers Grove Pediatrics is a proud participant of the program, Reach Out and Read (ROR). ROR is a national, nonprofit organization that promotes early literacy and school readiness. We incorporate ROR into well child checkups beginning at age 6 months by giving each child a new book at every appointment and encouraging families to read together.
Here is a link to learn more about Reach Out and Read.
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