November 28, 2023 Recalled Cinnamon Applesauce Pouches Causing High Blood Lead Levels in Children Various recalled cinnamon apple purée and applesauce products with elevated lead levels have been reported to the U.S. Food and Drug Administration (FDA). The recalled products have been the cause of 52 reported cases of illness in children, as of November 22. The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory to advise clinicians and health departments to report cases to their local health authorities. Background FDA, CDC, and state and local partners are investigating a potential link between high blood lead levels and consuming certain cinnamon-containing apple purée and applesauce products. State partners tested multiple lots of the reported products, and test results indicated the products contained extremely high levels of lead. WanaBana, Schnucks, and Weis have initiated voluntary recalls of certain lots of the following products: WanaBana brand apple cinnamon fruit purée pouches Schnucks brand cinnamon applesauce pouches Weis brand cinnamon applesauce pouches More Information More information about the specific recalled products may be found on the FDA’s website: Investigation of Elevated Lead Levels: Applesauce Pouches (November 2023) | FDA
April 24, 2023 April Recalls on Children’s Products Parents and caregivers should be aware of several child-related product recalls. Learn More Here is a list of April recalls collected from the following major federal agencies: the Consumer Product Safety Commission, the Food and Drug Administration, and the National Highway Traffic Safety Administration. Rollerblade USA recalled Rollerblade® Fury Inline Skates and Rollerblade® Fury Brake Supports due to fall hazard. Lucky Global recalled Lelinta Multi-Purpose Kids Helmets due to risk of head injury. Sold exclusively on Walmart.com. Lil Anglers recalled Children’s Fishing Rods Sold with Kid Casters No Tangle Combos due to violation of federal lead content ban. Bagno Milano recalled Children’s Robes due to violation of federal flammability standards and burn hazard. NewCosplay recalled Children’s Sleepwear due to violation of federal flammability standards and burn hazard. Sold exclusively at Amazon.com. FunnyPaja recalled Children’s Bathrobes due to violation of federal flammability standards and burn hazard. Sold exclusively at Amazon.com. Arshiner recalled Children’s Nightgowns due to violation of federal flammability standards and burn hazard. Sold exclusively on Amazon.com. Goumi recalled Children’s Robes due to violation of federal flammability standards and burn hazard. IKEA recalled BLAVINGAD Fishing Games due to choking hazard. Monti Kids recalled Basket with Balls/Toys due to choking hazard. Jetson Electric Bikes recalled 42-Volt Rogue Self-Balancing Scooters/Hoverboards due to fire hazard. Two deaths reported. Delta Enterprise Corp. recalled 2-in-1 Outdoor Kids Swings due to fall hazard. Cannondale recalled Tesoro Neo X Speed Electric Bicycles due to fall and injury hazards. Open Cycle recalled UP Ekar, UPPER Ekar, WIDE Ekar and MIND Ekar Bicycles due to crash hazard. Rico Perez Products, Inc. recalled 60-count bottles of Dr. Rico Perez Super Kids Colostrum Chewable Tablets due to undeclared milk allergen. More Information For recall details, visit the links above or review the Consumer Product Safety Commission, the Food and Drug Administration and the National Highway Traffic Safety Administration websites.
November 10, 2021 FDA Authorizes COVID-19 Vaccine for Emergency Use for Children Five to 11 The U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children five through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group. About the COVID-19 Vaccine The Pfizer-BioNTech COVID-19 Vaccine for children five through 11 years of age is administered as a two-dose primary series, three weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). In the U.S., COVID-19 cases in children five through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children five through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the five through 11 years age group. Pfizer Inc. has updated its safety monitoring plan to include evaluation of myocarditis, pericarditis and other events of interest in children five through 11 years of age. In addition, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the rapid detection and investigation of potential safety problems. Additional Information Additional information on the COVID-19 vaccine can be found on the FDA website.
July 16, 2020 FDA Warning: Hand Sanitizers Containing Methanol About On July 2, the U.S. Food & Drug Administration (FDA) issued a warning that there has been a sharp increase in hand sanitizer products labeled to contain ethanol (a.k.a. ethyl alcohol) but have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and toxic or life-threatening when ingested. Understanding the Risk Methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic side effects. The FDA is aware of instances where adults and children ingested contaminated hand sanitizers that have led to blindness, hospitalization, and death. The FDA’s investigation of methanol in certain hand sanitizers is still ongoing. Risks are especially high for young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute. Please do not ingest any type of hand sanitizer, regardless of whether or not it is contaminated with methanol. Receiving Medical Attention Individuals exposed to hand sanitizers containing methanol who are experiencing symptoms should seek immediate treatment for potential methanol poisoning. Substantial exposure to methanol can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. If you need to report adverse events or quality problems experienced with the use of hand sanitizers, contact the FDA’s MedWatch Adverse Event Reporting program online or through a printable form that can be submitted via fax at 1.800.332.0178. More Information A list of hand sanitizer products to avoid can be found on the FDA website. For more information, see the full update.
