Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC

Warning LetterClosed

Kunjal Joshi Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC 2004 Orville Drive North Ronkonkoma , NY 11779 United States kunjal@prodosepharma.com kunjal@spiritpharma.comIssued Mar 28, 2025Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateMar 28, 2025

Product TypeDrugs

StatusClosed

Closeout LetterMay 22, 2025

Letter Details

Firm: Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
Location: Kunjal Joshi Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC 2004 Orville Drive North Ronkonkoma , NY 11779 United States kunjal@prodosepharma.com kunjal@spiritpharma.com
FEI Number: N/A
Country: United States
Issue Date: March 28, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Closed
Closeout Letter: May 22, 2025

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.

Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC FDA Warning Letter, March 28, 2025