FDA WARNING_LETTER - Aphena Pharma Solutions-Tennessee, LLC

The FDA issued a Warning Letter to Aphena Pharma Solutions-Tennessee, LLC on December 5, 2017, regarding inaccurate drug product listing information for Fenofibrate 48mg (NDC 43353-248) and Montelukast Sodium (NDC 43353-252). This follows previous FDA letters on August 24, 2017, and October 12, 2017, which were not addressed.

The violations stem from the firm's failure to include correct copies of carton labels in their product listings, as required by Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the Fenofibrate 48mg listing included a carton label for Fenofibrate 145mg, and the Montelukast Sodium 5mg listing included a carton label for Montelukast Sodium 10mg.

These inaccuracies constitute a failure to fulfill listing obligations under Section 510(j), which is prohibited under Section 301(p) of the FD&C Act. Furthermore, this misbrands the products under Section 502(o), making their introduction into interstate commerce prohibited under Section 301(a).

As a result, the listing data for both products have been removed from the FDA's online NDC Directory. The firm must