RiteAid Corporation Warning Letter Details

Summary

RiteAid Corporation was cited for failures in drug listing and misbranding of its Mucus Relief DM product (NDC 11822-7224), a violation of Section 510(j) of the Federal Food, Drug, and Cosmetic Act. The company's electronic drug listing included phenylephrine HCl as an active ingredient, but this ingredient was not present on the product's actual label, creating a discrepancy between the submitted labeling and the eDRLS filing. This was a repeated violation, as FDA had previously notified the company of listing deficiencies in December 2021 and January 2022, ultimately resulting in removal of the product from the FDA's Online NDC Directory before the October 2022 warning letter was issued.