WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration announced further steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches, which were recalled earlier, prompted by findings of elevated blood lead levels in children.
The agency now said a warning letter was issued to retailer Dollar Tree, Inc. as it failed to adequately remove recalled WanaBana apple cinnamon fruit puree pouches from its store shelves. The move is part of the agency's ongoing post-incident response activities.
The FDA has also placed Negasmart, doing business as Sanchez Obando Alexander Ricardo, the distributor of the cinnamon used in the contaminated applesauce products, on multiple import alerts.
In addition, the FDA, following the recall of WanaBana apple cinnamon fruit puree pouch and its investigation, added Austrofood S.A.S., the manufacturer of the apple cinnamon fruit puree pouches, to import alert.
The agency said it has completed the initial response activities to investigate the source of the contamination and prevent additional illnesses, while it is continuing to explore prevention, compliance, and surveillance activities going forward.
It was in October last year that WanaBana USA called back all lots of WanaBana Apple Cinnamon Fruit Puree pouches due to reports of four illnesses caused by elevated levels of lead.
WanaBana Apple Cinnamon Fruit Puree in 3-pack pouches of 2.5 oz. were distributed nationwide through online and retail stores. WanaBana trade channels included Dollar Tree and Amazon, and they were also distributed independently in the US as private label brands of Schnucks and Weis.
The FDA now noted that in the weeks and months that followed the recall, public health officials across many states reported continuing to see recalled WanaBana apple cinnamon fruit puree pouches on Dollar Tree store shelves.
Noting that the retailers play a crucial role in carrying out the recall, the agency expressed its concern with Dollar Tree's capability to quickly remove unsafe products from its store shelves as necessary and as required during a public health threat, such as a recall. The company has been asked to respond within 15 days of receipt of the warning letter, stating the specific steps it has taken to address any violations and prevent the recurrence of violations, among others.
Further, Negasmart/Sanchez Obando Alexander Ricardo was placed on import alerts regarding products that appear to be adulterated for economic gain, as well as for products that are contaminated with heavy metals and appear to be adulterated.
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