| TOPIC: Apple Cinnamon Fruit Puree Pouches by WanaBana: Public Health Alert – FDA Advises Parents and Caregivers Not to Buy or Feed to Toddlers and Young Children Because of Elevated Lead Levels AUDIENCE: Pediatrics, Consumer, Caregivers ISSUE: The FDA is issuing this public health alert advising parents and caregivers not to purchase or feed WanaBana apple cinnamon fruit puree pouches to toddlers and young children because they may contain elevated levels of lead. The FDA was recently made aware of a developing investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity. The NCDHHS investigation identified WanaBana apple cinnamon fruit puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana apple cinnamon fruit puree, detecting extremely high concentrations of lead. The FDA has reviewed and supports NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm whose representatives are cooperating with the FDA and have agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration. WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Sam’s Club, Amazon and Dollar Tree. The FDA is continuing to work with state officials and the firm, collecting additional information, and taking steps to remove all contaminated product from the market.For more information about this alert, click on the red button “Read Alert” below. BACKGROUND: Signs and symptoms of lead toxicityLead is toxic to humans and can affect people of any age or health status. Protecting children from exposure to lead is important to lifelong good health. Lead exposure in children is often difficult to see. Most children have no obvious immediate symptoms. Although lead can only be diagnosed through clinical testing, signs and symptoms of lead toxicity vary based on exposure. Short term exposure to lead could result in the following symptoms: – Headache – Abdominal pain/Colic – Vomiting – Anemia Longer term exposure could result in additional symptoms: – Irritability – Lethargy – Fatigue – Muscle aches or muscle prickling/burning – Occasional abdominal discomfort – Constipation – Difficulty concentrating/Muscular exhaustibility – Headache – Tremor – Weight loss RECOMMENDATIONS: – Parents and caregivers of toddlers and young children who may have consumed WanaBana apple cinnamon fruit puree pouches should contact their child’s healthcare provider about getting a blood test. – Consumers who have symptoms should contact their health care provider to report their symptoms and receive care. – To report a complaint or adverse event (illness or serious allergic reaction), you can – Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem. – Complete an electronic Voluntary MedWatch form online. – Complete a paper Voluntary MedWatch form that can be mailed to FDA. – Visit www.fda.gov/fcic for additional consumer and industry assistance. Additional Information Health effects of lead exposure |
