FDA WARNING_LETTER - RiteAid Corporation - October 25, 2022

The FDA issued a Warning Letter to Ms. Horton regarding discrepancies in the drug listing information for "Mucus Relief DM, NDC 11822-7224." The electronic listing file includes phenylephrine hcl as an active ingredient, which is not present on the submitted labeling. This constitutes a violation of Section 510(j) of the FD&C Act and 21 CFR 207, which require accurate listing of all active pharmaceutical ingredients.

The FDA previously notified the firm of these deficiencies on December 6, 2021, and subsequently removed the product from FDA’s Online NDC Directory on January 20, 2022, due to continued non-compliance. Failure to properly list a drug also renders it misbranded under Section 502(o) and a prohibited act under Section 301(a) and 301(p) of the FD&C Act.

The FDA emphasizes that complete and accurate drug listing information is crucial for patient safety, drug establishment inspections, supply chain security, and post-market surveillance. The firm is required to investigate and correct the violations, and prevent recurrence. A written response detailing corrective actions, including supporting documentation, must be submitted to the FDA within 15 working days. Failure to address the matter may result in legal action, including seizure and injunction.