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Posts for category: Recalls

By contactus@priority-pediatrics.com
February 10, 2019
Category: Recalls

Infant ibuprofen recall expanded

A recall of infant ibuprofen has been expanded to include three more lots that could have high concentrations of the drug.

Tris Pharma Inc. has voluntarily recalled six lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 milligrams per 1.25 milliliters since December 2018.

The medication was sold in 0.5 ounce and 1-ounce bottles to reduce fever and pain under the Equate, CVS Health and Family Wellness brands at Walmart, CVS and Family Dollar stores, respectively. Additional details on lot numbers and expiration dates are available at https://www.fda.gov/Safety/Recalls/ucm630112.htm.

No adverse events have been reported to Tris Pharma Inc., but ibuprofen concentrations have been found as high as 10% above the specified limit, according to the company. The higher potency could cause nausea, vomiting, diarrhea, tinnitus, headache and gastrointestinal bleeding, according to the company. Infants may be more vulnerable to permanent kidney damage.

Customers with questions can contact Tris at 732-940-0358 or micc_tris@vigilarebp.com. Adverse reactions also can be reported to the Food and Drug Administration’s Medwatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.

The Academy recommends that children under 6 months avoid using ibuprofen unless directed by their doctor.

By contactus@priority-pediatrics.com
April 30, 2018
Category: Recalls
Tags: Untagged

 

 

Pacifier and teether holders

Units:About 590,000 in the U.S. and about 10,500 in Canada

Hazard: The snap can detach from the pacifier’s ribbon, and young children can choke on it.

Description: Dr. Brown’s Lovey pacifier and teether holders were sold in eight styles: giraffe, zebra, turtle, reindeer, frog, spring bunny, deer and bunny. Only holders with the following lot codes are recalled: RICH0615, RICH0715, RICH0815, RICH1215, RICH0516, RICH0616, RICH0716, RICH1116, RICH1016, RICH0916, RICH1216, RICH0317, RICH0417, RICH0517, RICH0617, RICH0717, RICH0817 and RICH0917. The lot codes are printed on the tag attached to the holder.

Sold at: Bed Bath & Beyond, H-E-B Grocery, Kmart, Target, Toys R Us/Babies R Us, Walmart and various stores nationwide and online at Amazon.com from August 2015 to March 2018 for about $10.

Remedy: Contact Handi-Craft to receive a replacement product or comparable merchandise of equal or lesser value.

Contact: Call 833-224-7674.

 

 

Smoke detectors

Units: About 452,000 in the U.S. and 40,000 in Canada

Hazard: A yellow cap left on during the manufacturing process can cover one of the two smoke sensors and compromise the smoke alarm’s ability to detect smoke, posing a risk of consumers not being alerted to a fire in their home.

Description: Models PI2010 (AC/hardwired) and PI9010 (DC/battery powered) of Kidde dual sensor (photoelectric and ionization) smoke alarms are recalled. KIDDE is printed on the front of the smoke alarm. The model number and date code 2016 Sep. 10 through 2017 Oct. 13 are printed on the back of the alarm.

Sold at: Menards, The Home Depot, Walmart and other department, home and hardware stores nationwide and online at Amazon.com, ShopKidde.com and other websites from September 2016 through January 2018 for $20 to $40.

Remedy: Remove the alarm from the wall/ceiling and look through the opening on the side of the alarm to see if there is a yellow cap. If there is a yellow cap, contact Kidde for instructions and a free replacement smoke alarm. Do not try to take apart the alarm, open the casing or remove the yellow cap. Remove and discard the recalled smoke alarm only after receiving and installing the replacement alarm. If no yellow cap is present, reinstall the smoke alarm.

Contact: Call Kidde at 833-551-7739 or visit www.kidde.com and click on Product Safety Recalls.

 

 

Children’s tents

Units: About 84,000

Hazard: The fiberglass rod that supports the tent can break and become sharp, posing a laceration hazard to consumers.

Description: The Playtime Pals Pop-Up Hideaway Hut children’s tent has four animal themes: hippo (pink), dog (brown), shark (blue) and tiger (orange). All have a fiberglass rod that springs to open the tent and supports the nylon shell.

Sold exclusively at: Home Depot stores nationwide during November 2017 for about $13.

Remedy: Return tents to Home Depot for a refund or store credit.

Contact: Call Jewett Cameron Company at 800-955-2879 or visit www.jewettcameron.com.

 

 

Children’s electric wagons 

Units: About 5,000

Hazard: Improper wiring can activate the wagon’s motor unintentionally, posing an injury hazard.

Description: Radio Flyer’s eWagon is a children’s battery-operated electric wagon constructed of red and gray fabric and a steel frame. When force is applied to the wagon’s electric handle, the motor activates to power the wagon. The wagon has a removable canopy, two seats with seatbelts, four cup holders, a storage pouch, a removable battery and a telescoping handle with the power button. Only wagons with model number 3912/3912A are recalled. The model number can be found on the handle warning label near the pivoting joint.

Sold at: Toys “R” Us stores nationwide and online at www.radioflyer.com and www.toysrus.com from August 2017 through January 2018 for about $350.

Remedy: Contact Radio Flyer for a refund.

Contact: Call Radio Flyer at 800-621-7613 or visit www.radioflyer.com/recalls.

By contactus@priority-pediatrics.com
April 25, 2017
Category: Recalls

FDA: More Homeopathic Teething Products Recalled

 
From AAP News 4/2017

 

Homeopathic teething tablets are being recalled due to potential health risks   to children, according to the Food and Drug Administration (FDA).

Standard Homeopathic Company in Los Angeles is voluntary recalling Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, which contain inconsistent amounts of belladonna, a toxic substance, that may differ from the calculated amount on the label.

“FDA reminds consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products,” the agency said in its alert to consumers.

The Hyland’s tablet recall follows FDA warnings in September and January and a recall of similar products from another manufacturer in November.

Standard Homeopathic Company said it stopped manufacturing the teething products in October 2016. Customers who still have these products should contact the manufacturer at 800-991-3376.

If a child experiences health issues potentially related to the tablets, contact the child’s health care provider. Those issues may include seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation, according to the FDA.

Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.

By contactus@priority-pediatrics.com
April 16, 2017
Category: Recalls
Tags: Recalls   Ventolin   albuteral   inhaler   asthma  

600,000 Albuterol Inhalers Recalled

 
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CNN · April 7, 2017By Robert Jimison

GlaxoSmithKline is recalling more than 590,000 albuterol inhalers. Three lots of Ventolin HFA 200D inhalers have been voluntarily recalled due to a potential issue with the delivery system, a spokesman for the British pharmaceutical company said.

The affected lot numbers are 6ZP0003, 6ZP9944 and 6ZP9848. The devices have been recalled from hospitals, pharmacies, retailers and wholesalers in the United States.

"There is possible risk that the affected inhalers could potentially not deliver the stated number of actuations," spokesman Juan Carlos Molina wrote in an email. "We continue to investigate the issue in order to identify the root cause and implement appropriate corrective and preventative actions."

It's not a patient-level recall, but patients whose inhalers are among the affected lots can contact GSK's customer service center at 1-888-825-5249 with questions. If the devices are not relieving symptoms, patients should seek medical treatment right away.

When functioning properly, the metered-dose inhaler releases a fixed dose of medication in aerosol form.

Metered-dose albuterol inhalers are used to deliver medication into the body through the airway and lungs. Albuterol opens airways in the lungs to treat common conditions such as asthma and chronic obstructive pulmonary disease.