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Safety Report: Nordic Naturals Baby’s Vitamin D3 - recalled due to Elevated level of Vitamin D3 dosage, USA

4 months ago source fda.gov

Recall notice

United States

Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid. This recall is being conducted due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose. There have been no reports of adverse events to date related to the use of this recalled product.

The recalled lot of Nordic Naturals Baby’s Vitamin D3 Liquid is 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3. The affected lot number is 234909, with an expiration date of December 2025. The affected product is used as a dietary supplement for infants up to 12 months of age and is packaged in boxes containing one bottle and one dropper for dosage, under SKU RUS-02733. Approximately 3,800 units of product were affected, with one-fifth already returned by retailers.

Prolonged use of the recalled Baby’s Vitamin D3 Liquid could potentially lead to elevated vitamin D levels, resulting in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.

Consumers, distributors, and retailers in possession of the recalled product should discontinue use immediately and return it to the place of purchase for a refund or replacement. The lot number can be found on the back of the box and on the bottle.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Nordic Naturals
Brand name: Nordic Naturals
Product recalled: Baby’s Vitamin D3 Liquid
Reason of the recall: Elevated level of Vitamin D3 dosage
FDA Recall date: February 19, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nordic-naturals-issues-voluntary-recall-babys-vitamin-d3-liquid-due-elevated-levels-vitamin-d3

#recall #dietarysupplements #us

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