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Posted February 6, 2013

Vitamin and Supplement Maker Warned For Labeling Errors, Manufacturing Violations

On January 25, 2013, the FDA issued a warning letter to NX Generation Ltd. following a facility inspection which found the company’s products, including Unique Children’s Chewable Vitamins and Unique Prenatal Care dietary supplement products, to be adulterated because the products were prepared, packed or held under conditions that violate current good manufacturing practices for dietary supplements. Violations include failure to maintain proper maintenance and quality control documentation.

The inspection also found that labels for Unique Children’s Chewable Vitamins and Unique Prenatal Care dietary supplements listed incorrect percent daily values (% DV) based on the established Recommended Daily Intake (RDI) for certain nutrients. For example, the Unique Children’s Chewable Vitamins label lists the incorrect %DV for Vitamin E and Niacin for both children of the age 2 to 4 and children age 4 and over. The label for Prenatal Care incorrectly lists the %DV for vitamin A, riboflavin, niacin, vitamin B6, folic Acid, vitamin B-12 and calcium.

See’s Review of Multivitamins and Multiminerals (including Prenatal and Children’s formulas) for tests of related products. For more information about the FDA’s warning letter, use the link below.