FDA WARNING_LETTER - Procter & Gamble Manufactura S. de R.L. de C.V. - March 21, 2023

The FDA issued a Warning Letter to Ms. Burke concerning the drug listing information for Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion (NDC 58933-541). An FDA review identified contradictory information between the product's labeling and its electronic listing file (eDRLS/SPL). Specifically, the active ingredients on the labeling (acetaminophen, dextromethorphan hbr, doxylamine succinate, and phenylephrine) did not match those in the SPL file, which incorrectly included guaifenesin and omitted doxylamine. This constitutes a failure to fulfill listing obligations under Section 510(j) of the FD&C Act and 21 CFR Part 207, making it a prohibited act under Section 301(p). Furthermore, the improper listing renders the drug misbranded under Section 502(o) and in violation of Section 301(a). The FDA emphasized that accurate drug listing is crucial for patient safety, inspections, and supply chain security. The firm's product data was previously removed from the Online NDC Directory due to these deficiencies. The firm must respond within 15 working days, detailing corrective actions and preventative measures. Failure to adequately address these violations could lead to legal actions such as seizure and injunction, and the deficient listing data will be inactivated.