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 firstname.lastname@example.org.
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.
As of Monday, July 11, 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are recommending that both children and adults stop using liquid docusate, a stool softener. Docusate is available by prescription and over-the-counter and may be known by its brand name Colace. Liquid docusate may be linked to a recent outbreak of a bacterial infection (B. cepacia complex), which the CDC and FDA are investigating.
Dr. and Mrs. Robinson welcomed their first great-grandchild, Avery, on April 20, 2016.
The US Food and Drug Administration (FDA) announced today that it wants to reduce the amount of inorganic arsenic in infant rice cereal to protect children from possible developmental problems.
The FDA released draft guidance for the food industry that sets a limit or action level of 100 parts per billion (ppb) for inorganic arsenic in this ubiquitous baby food. The agency also encourages parents to feed their infants a variety of iron-fortified cereals, and not only iron-fortified rice.
Pregnant women should diversify their grain consumption as well, because recent studies have linked intake of relatively high levels of inorganic arsenic to adverse pregnancy outcomes, the agency said in a news release. In addition, fetal exposure to inorganic arsenic together with dietary exposure during infancy can “result in a child’s decreased performance on certain developmental tests that measure learning.”
However, “consumers can certainly eat rice as part of a well-balanced diet,” the agency stated in a question-and-answer article on its website.
Reducing arsenic levels in rice is especially important for infants, the agency said, because relative to body weight, their intake of rice — primarily through cereal — is roughly three times greater than that for adults.
“Our actions are driven by our duty to protect the public health and our careful analysis of the data and the emerging science,” said Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, in the news release. “The proposed limit is a prudent and achievable step to reduce exposure to arsenic among infants.”
Cancer Risk Also Assessed
Good manufacturing practices, the agency said, can produce infant rice cereal that complies with the proposed arsenic limit. Most manufacturers are already close. Of 76 infant rice cereals recently tested by the FDA, 47% did not exceed the proposed limit of 100 ppb, and 78% were at or below 110 ppb. Nonrice foods for infants and toddlers, in contrast, tested well below 100 ppb.
The agency noted that inorganic arsenic found in rice cereal and other foods is not an additive or ingredient, but something naturally absorbed by all plants from water, soil, and air. Rice tends to absorb more arsenic than most. Unlike organic arsenic, inorganic arsenic is not bonded to carbon, and when found in food, it is the more toxic of the two forms.
As part of its risk assessment, the FDA mathematically modeled the incidence of lung and bladder cancer associated with consuming inorganic arsenic in rice and rice products. It estimated that this exposure causes an extra four cases of lung and bladder cancer over the lifetime for every 100,000 people in the United States, the agency said. “This estimate would account for far less than 1 percent of the nation’s lung and bladder cancer cases.”
The US Environmental Protection Agency, the National Institutes of Health, and the US Department of Agriculture reviewed the FDA’s risk assessment of inorganic arsenic, as did nongovernment experts.
Once the industry guidance regarding inorganic arsenic levels in infant rice cereal is published on the Federal Register, the FDA will accept public comments for 90 days.
More information on today’s announcement is available on the FDA website.
The FDA announced a recall of several lots of cough liquids due to incorrect markings on the oral dosing cups. The affected products were manufactured by Perrigo, and distributed under several brand and store labels (e.g. CVS). A complete listing of affected product names, lot numbers, and consumer directions are posted on the FDA’s website, linked here: http://www.fda.gov/Safety/Recalls/ucm481411.htm
Sanofi US is recalling ALL Auvi-Q epinephrine injection currently on the market.
Patients with questions regarding this recall can go to the company website www.auvi-q.com and call 1‑877‑319‑8963 or 1‑866‑726‑6340 Monday through Friday 8 a.m. to 8 p.m. ET for information about how to return their Auvi‑Q devices. Sanofi US will provide reimbursement for out of pocket costs incurred for the purchase of new epinephrine auto‑injectors with proof of purchase.
Call our office if you need an alternate prescription.
The Massachusetts Department of Public Health is announcing the expanded availability of human papilloma virus (HPV) vaccine and meningococcal conjugate four-valent (MCV4) vaccines effective November 1, 2015 for all children through 18 years of age regardless of insurance status.
We have recently received our first shipment of flu vaccine for the 2015-2016 season.
Flu vaccine will be offered when you bring your child in for routine care. We will also be administering the flu vaccine by appointment only Tuesday through Friday throughout the flu season. Please call early in the day to schedule a same day nurse visit. Please call the nurse’s line 781 356 6200 option 3 during regular business hours to schedule an appointment.
CDC recommends that everyone 6 months of age and older get a seasonal flu vaccine. This includes all children aged 6 months up to their 19th birthday. 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, if they get the flu.
Click the link below for additional information about the flu vaccine:
Currently we have flu vaccine available in the injectable form. Due to a manufacturer’s shortage, we do not have the intranasal form (Flumist) at this time. Flumist is approved for children age 2 and above, although not for those with certain health issues (allergic to eggs, gentamicin, gelatin, or arginine, are currently wheezing; have a history of wheezing, have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with heart, kidneys or lungs; have diabetes). 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.
Please see the following message from the American Academy of Pediatrics:
American Academy of Pediatrics President Urges Parents to Vaccinate Their Children Against Measles
Statement by Sandra G. Hassink, MD, FAAP
As the measles outbreak linked to Disneyland continues to spread, pediatricians are deeply concerned about the children who have been infected, and those who are at risk because they have not been vaccinated. The American Academy of Pediatrics strongly urges parents to make sure their children have received the measles, mumps and rubella (MMR) vaccine. While it is best to get the vaccine as soon as your child reaches the recommended age, it is never too late to get your children caught up so they can receive the vaccine and be fully protected.
We know from many repeated studies that the MMR vaccine is safe and effective. It is in fact one of the most effective vaccines we have. And as the measles outbreak has shown, this virus is incredibly contagious. If you have not been immunized against measles and come near an infected person, you have a 90 percent chance of getting measles.
An infected person may not show symptoms for four days — meanwhile he or she can expose dozens of other people they encounter in daily life, at the park, grocery store, school, and other places where children commonly are. Measles affects all organs of the body, and can cause serious and in some cases life-threatening complications in children including pneumonia and encephalitis.
When measles was more common in the U.S., hundreds of children died from this virus every year. The fact that this disease has resurfaced for the first time in more than a decade has prompted pediatricians to reiterate the same recommendation to parents that we’ve made for decades with renewed urgency: Vaccines work. Delaying your child’s vaccines, or refusing the vaccine, leaves your child vulnerable to this invisible threat. And puts other children in the community at risk.
Some children cannot be vaccinated because of problems with their immune system, or because they are too young to be vaccinated. It is heartbreaking to know that these vulnerable children may be at risk if parents refuse or delay getting their children vaccinated, allowing community immunization rates to fall below the rates necessary to protect the whole community. To protect your own child, as well as the other children in your community, make the decision to vaccinate your child. If you have questions about measles or vaccines, we encourage you to talk with your child’s pediatrician.
To help parents, the AAP has also assembled these resources:
- HealthyChildren.org: How to Protect Your Children During a Measles Outbreak
- Healthy Children Radio: Interview with COID member Dr. Kathryn Edwards
- News release: AAP urges parents to vaccinate children to protect against measles
Effective 6/11/2014, Milton Pediatrics will no longer charge for health forms.
Please make copies or scan a copy into your computer if you feel you may need additional forms throughout the year.
MassGeneral for Children has opened a specialists office location in our building. Please see below for more information:
We are pleased to announce the opening of our new MassGeneral for Children (MGfC) community location in Braintree, MA.
Located at 340 Wood Road, our newest community location is now open and will continue to add specialties throughout the summer.
At this new location, patients will have access to MGfC specialists in:
- Allergy (July 2014)
- Cardiology – now scheduling appointments
- Endocrinology – now scheduling appointments
- Gastroenterology – now scheduling appointments
- Nephrology (July 2014)
- Pulmonology (July 2014)
- Pediatric Surgery – now scheduling appointments
- Rheumatology (September 2014)
Visits can be scheduled for the new location through each specialty service or by calling the MGHfC Access and New Appointment Center at 888-644-3248. For more information, visit the MGHfC community locations page.