FDA WARNING_LETTER - Prodose, Inc. - April 29, 2025

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This FDA Warning Letter, dated March 28, 2025, addresses Spirit Pharmaceuticals LLC (now Prodose, Inc.) regarding drug listing violations for their product, Maximum Strength Nighttime Severe Cold and Flu, NDC 68210-4210.

The FDA previously communicated these issues on March 30, 2023, and again via a deficiency letter on December 30, 2024, and a data removal notification on February 13, 2025, due to continued deficiencies.

Violations include: 1. **Incorrect Active Ingredient Strength:** The strength of doxylamine succinate in the labeling (6.25 mg) does not match the structured product labeling (SPL) basis of strength field ((b)(4)). This violates 21 CFR 207.49(a)(4). 2. **Mismatched Product Name:** The proprietary name on the principal display panel image is "Maximum Strength Nighttime Severe Cold and Flu," but the listed name spells "severe" as "sever."

These issues mean the firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act (21 U.S.C. 360(j)), which is a prohibited act under section 301(p) (21 U.S.C. 331(

Company: Prodose, Inc.
Inspection Date: April 29, 2025
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Kunjal Joshi
Tina Smith (Director)
James Flahive

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ID · 36e6ee9e-67f7-491a-96ca-d00e3c75b5ec

Violation Codes8

21 U.S.C. 331(a)21 U.S.C. 360(j)21 CFR 20721 CFR 207.33(c)21 CFR 207.57(b)(2)21 CFR 207.49(a)(4)21 U.S.C. 352(o)21 U.S.C. 331(p)

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