Friday, November 3, 2023

Pouches of Apple Fruit Puree with Cinnamon Recalled After 4 Children Suffer from Acute Lead Toxicity

The FDA issued a public health alert for WanaBana apple cinnamon fruit puree after the NC Dept of Health  identified the product as being the source of lead that caused elevated lead levels in 4 children.  "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 is advising parents and caregivers not to buy or feed WanaBana apple cinnamon fruit puree pouches to children because the product may contain elevated levels of lead. 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."



https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-parents-and-caregivers-not-buy-or-feed-wanabana-apple-cinnamon-fruit-puree-pouches
FDA Advises Parents and Caregivers Not to Buy or Feed WanaBana Apple Cinnamon Fruit Puree Pouches to Toddlers and Young Children Because of Elevated Lead Levels

Audience
  • Parents and caregivers of toddlers and young children who have recently purchased WanaBana apple cinnamon fruit puree pouches.
Product
  • WanaBana apple cinnamon fruit puree pouches, all lot codes and expiration dates.
  • WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Sam’s Club, Amazon and Dollar Tree.
  • WanaBana has agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.
Purpose

The FDA is advising parents and caregivers not to buy or feed WanaBana apple cinnamon fruit puree pouches to children because the product may contain elevated levels of lead. 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.

Signs and symptoms of lead toxicity

Lead 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. If there’s suspicion that a child may have been exposed to lead, parents should talk to their child’s healthcare provider about getting a blood test. 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

Summary of Problem and Scope

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.

FDA Actions

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 is continuing to work with state officials and the firm, collecting additional information, and taking steps to remove all contaminated product from the market.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wanabana-issues-voluntary-recall-wanabana-apple-cinnamon-fruit-puree-pouches-due-elevated-lead
WanaBana Issues Voluntary Recall of WanaBana Apple Cinnamon Fruit Purée Pouches Due to Elevated Lead Levels
Summary
Company Announcement Date: October 30, 2023
FDA Publish Date: October 31, 2023
Product Type: Food & Beverages
Reason for Announcement: Elevated levels of lead
Company Name:Wanabana LLC
Brand Name:  Wana Bana
Product Description:  Wana Bana Apple Cinnamon Fruit Puree 2.5 oz

Company Announcement

For Immediate Release – October 29, 2023 - United States - WanaBana USA is voluntarily recalling WanaBana Apple Cinnamon Fruit Purée pouches due to reports of elevated levels of lead found in certain units of the product.

Lead 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. If you suspect that your child might have consumed this product, parents should talk to your child’s healthcare provider about getting a blood lead test. Lead poisoning can only be diagnosed through clinical testing. Although signs and symptoms of lead toxicity vary, 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

WanaBana Apple Cinnamon Fruit Purée Pouches were distributed nationwide through online and retail stores. The affected product information is as follows:

Product Name: WanaBana Apple Cinnamon Fruit Puree in 3-pack pouches of 2.5 oz. Affected Batches:
Batch Units Batch Units
10022:21 33165 01023:03 48735
11022: 08 22185 01023:17 62235
11022:09 23730 01023:23 67590
11022:10 33420 01023:27 60975
11022:12 12120 01023:30 101205
11022:14 29025 01023:31 99180
11022:15 32085 02023:07 84780
11022:16 34860 02023:18 129600
12022:23 64170 04023:23 96090
04023:24 138240
04023:25 64395
04023:26 68805
05023:08 85950
05023:09 101520
05023:10 89460
05023:11 95535
05023:15 88605
10022:31 33165

WanaBana USA has initiated a voluntary recall of the affected batches and is working closely with the FDA to investigate the source of the contamination. The company is committed to ensuring the safety of its products and the well-being of its consumers.

Four illnesses have been reported to date, leading North Carolina Department of Agriculture and Consumer Services and the North Carolina Department of Health and Human Services to investigate and sample the pouches. North Carolina’s analyses came back with elevated concentrations of lead which could result in acute toxicity. WanaBana USA is working to investigate the source of the contamination.

Consumers who have purchased WanaBana Apple Cinnamon Fruit Puree Pouches with the specified batch numbers and expiration dates are urged to stop using the product immediately and return it to the place of purchase for a full refund. Parents and caregivers of toddlers and young children who may have been exposed to lead should contact their health care provider to report their symptoms and receive care. Consumers with questions can email the company at support@wanabanafruits.com.

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