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Daily Dose

Rotarix Vaccine Temporarily Suspended

The FDA suspends Glaxo Rotarix vaccine I received the CDC Health Alert yesterday afternoon notifying physicians to “temporarily suspend the usage of GlaxoSmithKline (GSK) Rotarix (rotavirus) vaccine. Rotarix was licensed for use in 2008 to prevent rotavirus disease, which typically causes fever, vomiting and diarrhea in infants and young children.

Prior to this Merck’s vaccine RotaTeq had been licensed for us in 2006. Both of these vaccines are given orally. Both RotaTeq and Rotarix were found to prevent serious rotavirus illness and hospitalizations for dehydration. The GSK product, Rotarix, which is a “live attenuated” vaccine, has been found to contain DNA from porcine circovirus type 1 (PCV 1). PCV 1 virus is not known to multiply in human cells or to cause illness.  According to the FDA, “all available evidence indicates that there had been no increased risk to patients who have received this vaccine”.  The GSK vaccine, Rotarix, is made in a different manner than the Merck vaccine RotaTeq.  Preliminary studies by the FDA on RotaTeq vaccine have not shown the presence of PCV 1 DNA. Preliminary data reported to the FDA  by GSK related to PCV 1 being in the vaccine seems to suggest that it has been present since the early stages of the vaccine’s development.  Studies on Rotarix, both before and after the approval of the vaccine, have shown it to be extremely safe and no unusual adverse events have been reported.  At the same time, the vaccines that have been given are presumed to be effective. In the interim, while futher studies are being completed, it is recommended that children continue to receive RotaTeq vaccine.  The FDA plans to convene an advisory committee to look into how the DNA components came to be present in this vaccine. They are also going to look into the use of new techniques for identifying viruses in vaccines.  After this meeting, the FDA will make further recommendations about the use of rotavirus vaccines in the United States. This recall was limited to the United States, and children in other areas or the world are continuing to receive Rotarix, as the available evidence suggests that the benefits of the vaccine outweigh the risks, especially in areas where rotavirus disease causes severe disease and even deaths. I would not be alarmed if my baby had received this vaccine as it does not cause disease in animals or humans.  I would also complete my child’s vaccine series with the Merck product which is available.  We will all have to stay tuned for further details,  but this should also make parents aware that the safety of vaccines continues to be monitored, even after they have been approved. That's your daily dose for today.  We'll chat again tomorrow! Send Dr. Sue your question now!

Your Child

Recall: Children’s Cough Syrup

1:30

Parents are being urged to check their medicine cabinets as two batches of generic children's cough syrup are removed from pharmacy shelves across the country. They have been recalled due to overdose risk.

The voluntary recall was initiated after it was discovered the dosage cups included in the box had incorrect markings, leading to fears that children may be given too much medication, according to a statement from the manufacturer.

The products in question are:

·      Children's guaifenesin grape liquid (100mg/5 mL)

·      Children's guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles

Each includes a small plastic cup.                  

The over-the-counter cough syrups are sold generically nationwide, under different brand names:

GUAIFENESIN GRAPE LIQ 4 OZ

·      H.E.B

·      CVS

GUAIFENESIN DM CHRY LIQ 4 OZ

·      Sunmark

•       Rite-Aid

•       Topcare

•       Kroger

•       GoodSense

•       Dollar General

•       Care One

•       CVS

The U.S. Food and Drug Administration said it is aware of the voluntary recall and urged consumers who bought the batches listed above "to discard the dosing device and product."

While there have been no reported overdoses related to the medication, the Perrigo Company said side effects of an overdose can include "hyperexcitability, rapid eye movements, changes in muscle reflexes, ataxia, dystonia, hallucinations, stupor and coma," adding that other effects have included "nausea, vomiting, tachycardia, irregular heartbeat, seizures, respiratory depression and death."

Source: Amy La Porte, http://www.cnn.com/2016/01/12/health/childrens-cough-syrup-recalled/

Parenting

Samsung Recalls I Million Galaxy Note 7 Smartphones

1:00

According to the Pew Research Center, 9 out of 10 Americans own a cell phone. That includes adults, teens and children. If you or a family member owns a Samsung Galaxy Note 7 smartphone, you need to stop using it and contact your wireless carrier or a Samsung retail outlet.

Samsung issued a warning about a week ago warning U.S. consumers to stop using the new Galaxy Note 7 smartphones.

Today, the Consumer Product Safety Commission (CPSC) announced a recall of about 1 million of the smart-phones because the lithium-ion battery in the Galaxy Note7 smartphones can overheat and catch fire, posing a serious burn hazard to consumers.

Samsung has received 92 reports of the batteries overheating in the U.S., including 26 reports of burns and 55 of property damage from fires in cars and a garage, the agency said.

This is “such a serious fire hazard I urge all consumers to take advantage of this recall right away,” Elliot Kaye, chairman of the CPSC told a news conference late Thursday. 

This recall involves the Samsung Galaxy Note7 smartphone sold before September 15, 2016.  The recalled devices have a 5.7 inch screen and were sold in the following colors:  black onyx, blue coral, gold platinum and silver titanium with a matching stylus. Samsung is printed on the top front of the phone and Galaxy Note7 is printed on the back of the phone. 

To determine if your phone has been recalled, locate the IMEI number on the back of the phone or the packaging, and enter the IMEI number into the online registration site www.samsung.com or call Samsung toll-free at 844-365-6197.

The smartphones were sold at wireless carriers and electronic stores nationwide, including AT&T, Best Buy, Sprint, T-Mobile, US Cellular, Verizon stores and online at www.samsung.com and other websites from August 2016 through September 2016 for between $850 and $890.

You can find a list of the wireless and retailer phone numbers and websites at http://www.cpsc.gov/en/Recalls/2016/Samsung-Recalls-Galaxy-Note7-Smartphones/

 

 

 

Parenting

Recall: Cracker Barrel’s Animated Toy Monkey Due to Burns

1:45

Giggles International is recalling about 13,000 of their Animated Sing Along Monkey toy due to the possibility that the battery compartment can reach temperatures up to 230 degrees Fahrenheit, posing a burn hazard for children.

This recall involves Giggles International Animated Sing-Along Monkey toys. The monkey is made of brown and beige plush material and is about 9 inches tall. The toy is designed to hold a songbook titled "5 Little Monkeys" and to sing the song when activated. A red music note is on the bottom of the monkey's right foot and the face of a child with its hands covering its eyes are on the bottom of the money's left foot. Recalled sing-along monkeys were manufactured between 6/7/2014 and 7/5/2014 and have batch code GP1410028.  

The manufacture date in the M/D/YYYY format and batch code are printed on the bottom of a white fabric label attached near the base of the monkey's tail. The monkey toys came in a tan colored box with words "Animated Sing-Along Monkey," "Sing along with me!" and "I play peek-a-boo with you!" on the front. The age advisory "For ages 3+" and the warning that batteries are included are also on the front of the box.

Giggles International has received two reports of toys overheating and melting their battery compartments.

The toy is sold exclusively at Cracker Barrel Old Country Stores nationwide from September 2014 to October 2014 for about $25.

Consumers should immediately take the animated monkey away from children, remove the batteries and return the toy to any Cracker Barrel Old Country Store or contact Giggles International for a full refund.

You can contact Giggles International at (800) 738-6018 from 9 a.m. to 6 p.m. ET Monday through Friday or online at www.LoveMyGiggles.com and click on Recall at the top of the page for more information.

Toy monkey recall

Your Baby

49,000 Britax B-Ready Baby Strollers Recalled

1:45

About 49,000 Britax B-Ready strollers have been recalled because the foam padding on the stroller’s arm bar can come off in fragments if the child bites the arm bar, posing a choking hazard.

This recall involves Britax B-Ready strollers and B-Ready replacement top seats that were sold separately. The B-Ready strollers have a silver or black frame with a solid-colored top seat in a variety of colors. The Britax logo is on the stroller’s side hinges and foot rest. B-Ready is printed on the sides of the stroller frame.  The stroller’s model number and date of manufacture are printed on a label on the stroller’s frame between the front wheels or on the inside frame that connects to the back right wheel. The replacement top seats were sold separately in a variety of colors and fit into the stroller’s frame. The replacement top seat’s model number and date of manufacture are printed on a black label on the right side tube above the adjuster button, under the fabric cover.

Britax has received 117 reports of children biting the arm bar foam padding, including five reports of children choking or gagging on foam fragments.

Consumers should immediately remove the arm bar from recalled strollers and replacement top seats and contact Britax for a free black, zippered arm bar cover and a warning label to apply to the strollers and replacement top seats. Consumers can continue to use their strollers without the arm bar attached.

The strollers were sold at Babies R Us, buybuy Baby, Target and other stores nationwide and online at Amazon.com, Diapers.com and other websites from April 2010 through January 2016 for about $500 for the stroller. Britax sold the replacement top seats from April 2010 through January 2016 for about $150.

The model numbers for the B-Ready Strollers are:

U281767, U281768, U281771, U281772, U281773, U281774, U281784, U281792, U281793, U281794, U281795, U281796, U281797.

The B-Ready replacement top seats model numbers are:

S845600, S845700, S845800, S845900, S855000, S855100, S856600, S870200, S870300, S870600

These models were sold April 1, 2010 (2010/04/01) through Dec. 31, 2012 (2012/12/31).

 Consumers can contact Britax at 800-683-2045 from 8:30 a.m. to 5:45 p.m. ET Monday through Thursday and from 8:30 a.m. to 4:45 p.m. ET on Friday, by email at Britax.Recall@britax.com or online at www.us.britax.com and click on Safety Notice at the top right, or  www.B-ReadyRecall.com for more information.

Source: http://www.cpsc.gov/en/Recalls/2016/Britax-Recalls-Strollers-and-Replacement-Top-Seats/

Your Baby

Recall: Infant Bathtubs Due to Drowning and Impact Injury

1:30

This recall involves 86,000 Summer Infant Lil’ Luxuries Whirlpool, Bubbling Spa & Shower with fabric slings.

Fabric slings on the recalled infant bathtubs can detach from the tub, posing a risk of impact injury and drowning.

CPSC and Summer Infant have received reports of 91 incidents of the sling detaching, including 11 reports of infants who received a bump to the head.

The infant bathtub is a battery-operated whirlpool bath with motorized jets intended for use with children from birth to 2 years. The product contains a fabric sling on a plastic frame onto which the infant is placed for bathing. The fabric sling on the recalled bathtubs does not have a white plastic attachment clip to hold the headrest area of the fabric sling to the plastic frame.

Recalled bathtubs have item numbers 18840, 18850, 18863, and 18873 and were sold between October 2012 and October 2013 with date codes starting with 1210, 1211, 1212, 1301, 1302, 1303, 1304, 1305, 1306, 1307, and 1308, which stand for the two-digit year followed by the two-digit month, on the fabric sling.

Consumers should immediately stop using the fabric sling in the recalled product and contact Summer Infant for a replacement fabric sling with a white plastic attachment clip. Consumers can contact Summer Infant toll free at 844-612-4254 from 9 a.m. to 5 p.m. ET Monday through Thursday and 9 a.m. to 3 p.m. ET on Friday, or online at www.summerinfant.com and click on “Safety Alerts & Recalls” at the bottom of the page for more information.

The recalled items were sold at Toys R Us/Babies R Us and other juvenile product specialty stores nationwide from October 2012 through October 2013 for about $60. CPSC and Summer Infant warn consumers that these tubs could have been and could continue to be sold on the secondhand market.

 

Your Baby

IKEA Recalls 169,000 Crib Mattresses

1:30

Swedish furniture maker IKEA is recalling about 169,000 of their VYSSA crib mattress because of the risk that infants can become trapped between the mattress and the crib.

The firm has received two reports of infants becoming entrapped between the mattress and an end of the crib. The children were removed from the gap without injury.

The mattresses were sold exclusively at IKEA stores and online from August 2010 to May 2014 for about $100.00.

This recall involves IKEA VYSSA style crib mattresses with the following five model names:

·      VACKERT

·      VINKA

·      SPELEVINK

·      SLÖA

·      SLUMMER.

The involved mattresses were manufactured on May 4, 2014 or earlier. An identification label attached to the mattress cover has the date of manufacture in Month-DD-YYYY format and the VYSSA model name. A gap between the mattress and crib ends larger than two-finger width is an indication of the defective mattress.

Consumers should inspect the recalled mattress by making sure there is no gap larger than the width of two fingers between the ends of the crib and the mattress. If any gap is larger, customers should immediately stop using the recalled mattresses and return it to any IKEA store for an exchange or a full refund.

Consumers can contact IKEA toll-free at (888) 966-4532 anytime or online at www.ikea-usa.com and click on the recall link at the top of the page for more information.

Source: http://www.cpsc.gov/en/Recalls/2015/IKEA-Recalls-Crib-Mattresses/

Your Toddler

High Chair Recall Due to Fall Danger

1:30

Nuna Baby Essentials has recalled eight models of their baby high chairs because the arm bar can bend or detach during use, posing a fall hazard to children.

Nuna has received 50 reports of the arm bar detaching, including six reports of children falling from the high chair. Four incidents resulted in injuries, including bruising and a cut on the forehead.

This recall includes ZAAZTM high chairs in eight models: HC-07-004 (pewter), HC-07-005 (carbon), HC-07-006 (plum), HC-07-009 (almond), HC-08-004 (pewter), HC-08-005 (carbon), HC-08-006 (plum) and HC-08-009 (almond). ZAAZ and the model number are printed under the high chair seat on a white sticker. These high chairs look like a regular kitchen table chair and have removable trays, arm bars footrests, seat pads and harnesses so that they can convert into toddler chairs. “Nuna” is printed above the footrest of the unit.

The high chairs were sold at Albee Baby, Giggle, Magic Bean, Nordstrom and other specialty stores nationwide and online at www.nuna.eu and www.wayfair.com and other online retailers from February 2013 through November 2015 for about between $250 and $300. 

Consumers should immediately stop using these recalled high chairs and contact the firm to receive a free new arm bar and instructions on how to replace it.

For more information, Nuna Baby Essentials has a toll-free number at 855-686-2872 from 8:30 a.m. to 4:30 p.m. ET Monday through Friday. Or consumers can go online at www.nuna.eu/usa/ and click on “Product Recall” under the “Support” section on the sidebar of the homepage for more information.

Source; http://www.cpsc.gov/en/Recalls/2016/Nuna-Baby-Essentials-Recalls-High-Chairs/

Parenting

Recall: Samsung Washing Machine –Top Can Detach

1:30

Washing machines are a necessity for growing families. If you own a Samsung top-loading washer, family members could be in danger of being injured if the top detaches during use.

About 2.8 million Samsung top-loading washing machines are being recalled after 733 reports of the washing machines experiencing excessive vibration or the top detaching from the washing machine chassis.  There are nine related reports of injuries, including a broken jaw, injured shoulder, and other impact or fall-related injuries.

This recall involves 34 models of Samsung top-load washing machines.  The washing machines have mid-controls or rear-controls. Model numbers and serial information can be found on two labels affixed to the back of the machine.. Consumers should check with Samsung to see if their washer is recalled.

A list of the models affected by this recall can be found online at www.Samsung.com and click on the recall notice at the top of the page for more information. You can also call 866-264-5636 from 8 a.m. to 10:00 p.m. Eastern Standard Time.

If you own one of the recalled models, contact Samsung immediately to receive one of the following remedy options. Consumers can choose (1) a free in-home repair that includes reinforcement of the washer’s top and a free one-year extension of the manufacturer’s warranty; (2) a rebate to be applied towards the purchase of a new Samsung or other brand washing machine, along with free installation of the new unit and removal of old unit; or (3) a full refund for consumers who purchased their washing machine within the past 30 days of the recall announcement.

All known consumers will also receive a Home Label Kit that includes a control panel guide and additional safety instructions in the mail.

Until they have received and installed a Home Label Kit, consumers should only use the delicate or waterproof cycles when washing bedding, water-resistant and bulky items.  The lower spin speed in the delicate or waterproof cycles lessens the risk of the washing machine top unexpectedly detaching from the washing machine chassis.

The washing machines were sold at Best Buy, The Home Depot, Lowes, Sears and other home appliance stores nationwide from March 2011 to November 2016 for between $450 and $1,500.

Story source: https://www.cpsc.gov/Recalls/2017/Samsung-Recalls-Top-Load-Washing-Machines

  

 

 

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