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Cross Contamination with Other Products
Undeclared wheat, soy flour and soy lecithin
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Sea Salt Almond Allegator candy has a back label for chocolate covered cherries.
Products contain undeclared FD&C Yellow No. 5
Label mix-up product is labeled as black peppercorn but is actually Pink Himalayan salt
Coconut is declared in the ingredient list, but not declared in the contains statement in coconut paste.
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
During an inspection by NCDA, the firm was notified that the product label fails to list any sub ingredients.
During an inspection by NCDA, the firm was notified that the product label fails to list any ingredients.
During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
During an inspection by NCDA, the firm was notified that the label fails to list any sub ingredients.
During an inspection by NCDA, the firm was notified that the label fails list any sub ingredients.
During an inspection by NCDA, the firm was notified that the label does not list any ingredients in the product.
During an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.