The maker of Hyland’s Teething Tablets, previously removed from the market due to inconsistent levels of potentially toxic substances, has now issued a recall for all remaining packages. Please see further information here: https://www.fda.gov/Safety/Recalls/ucm552934.htm.
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|
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@example.com.
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.
Our Phones and systems are now working. When calling the offices please use the contact phone numbers for the corresponding office. The temporary email used yesterday is no longer in service and it is not monitored please discontinue using this method to reach out to us.
Thank you all so much for your patience and understanding during yesterdays outage.
We are experiencing phone and systems outages in our Braintree office.
Please call 617-724-0924 for any after hours questions, or concerns regarding your child/ren.
Please do not email us using the email we had stated earlier, that email is not monitored after hours.
Please call 911 with any life-threatening concerns.
We apologize for any inconvenience this may cause.
Due to the inclement weather, our office will be closed on Tuesday March 14, 2017.
Due to the inclement weather, our office will be opening at noon on Monday February 13, 2017.
We have opened up flu clinics for the 2016-2017 flu season. The Flu vaccine will be administered by appointment only Monday through Friday and some Saturdays throughout the flu season. Please call 781-356-6200 during regular business hours to schedule an appointment.
We have recently received our first shipment of flu vaccine for the 2016-2017 season.
Flu vaccines can be given when you bring your child in for routine care. We will also be administering the flu vaccine at nurse visits by appointment only Tuesday through Friday throughout the flu season. Please call the nurse’s line 781-356-6200 option 3 during regular business hours to schedule an appointment. Please call in the morning to arrange same day appointments; appointments for a later date can be arranged as well.
The Center for Disease Control and Prevention recommends that everyone 6 months of age and older get a seasonal flu vaccine. Vaccination is especially important for children younger than 5 years of age and children of any age with a long-term health condition like asthma, diabetes and heart disease. These children are at higher risk of serious flu complications.
Click the link below for additional information about the flu vaccine:
We will not be offering the nasal spray version of the flu vaccine, FluMist, this year. The CDC has recommended against the administration of the FluMist this year due to poor efficacy the past few flu seasons. http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html Please be advised that occasionally throughout the season we may be may be temporarily out of some formulations of the vaccines. These supplies are replenished as we receive additional shipments from the state.
Please speak to our nursing staff if you have any questions about the flu vaccine.
Dr. McCullough and her husband Craig welcomed Addison McCullough on July 13, 2016.