Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC Warning Letter Details

Summary

Prodose, Inc. was cited for failing to properly list its drug product "Maximum Strength Nighttime Severe Cold and Flu" (NDC 68210-4210) in FDA's electronic Drug Registration and Listing System (eDRLS), a violation of section 510(j) of the Federal Food, Drug, and Cosmetic Act. The company's listing submission contained multiple discrepancies: the active ingredient doxylamine succinate strength was inconsistent between the product labeling (6.25 mg) and the structured product labeling (SPL) section, and the product name was misspelled in the listing as "sever" rather than "severe." The FDA had previously notified the company of these listing deficiencies in March 2023, making this a repeat compliance failure.