Nordic Naturals is recalling one lot of Baby’s Vitamin D3 Liquid citing elevated level of Vitamin D3 dosage, according to the U.S. Food and Drug Administration.
The affected product is used as a dietary supplement for infants up to 12 months of age.
The recall involves lot number 234909 of Baby’s Vitamin D3 Liquid, 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3, with an expiration date of December 2025. Around 3,800 units of product were affected, with one-fifth already returned by retailers. It is packaged in boxes containing one bottle and one dropper for dosage, under SKU RUS-02733.
The recall was initiated due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose.
The agency noted that prolonged use of the recalled liquid could potentially lead to elevated vitamin D levels. This could result in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.
However, there have been no reports of adverse events related to the recalled product to date.
Nordic Naturals is notifying distributors, retailers and customers, and urging them to discontinue its use immediately and return it to the place of purchase for a refund or replacement.
In recent recalls involving drug products, Neptune Resources, LLC in late January called back all lots of Neptune’s Fix products citing the presence of tianeptine, an ingredient that is not FDA-approved for any medical use.
Azurity Pharmaceuticals, Inc. in late January recalled one lot of Narcolepsy drug Zenzedi CII 30 mg to the consumer level, due to a mislabeled package during manufacturing.
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