Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC - 654751 - 03/28/2025

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WARNING LETTER

March 28, 2025

RE: 2851 (CMS 654751)

Dear Kunjal Joshi:

This letter concerns your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210.¹ FDA has previously communicated to Spirit Pharmaceuticals LLC (“Spirit”) that this drug product is not properly listed. Refer to correspondence sent to Spirit on March 30, 2023.²

We reiterate that your firm has not fulfilled its listing obligations under section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). These violations are described in more detail below.

Drug Listing Violations

Section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207 outline the requirements for registration and listing of drug products. Under 21 CFR 207.49(a)(4), a firm must include in the listing submission to FDA, among other requirements, the name and quantity of each active pharmaceutical ingredient in the listed drug. A review of the listing for Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, reveals that the strength of the active ingredient, doxylamine succinate, does not match between the labeling and the structured product labeling (SPL) sections of the listing submission. Specifically, in the labeling, the strength of the active ingredient, doxylamine succinate, is stated as 6.25 mg however, in the SPL’s basis of strength field, the strength of doxylamine succinate is listed as (b)(4) Additionally, the name in the product listing does not match the name on the product labeling. Specifically, while the proprietary name on the principal display panel image is Maximum Strength Nighttime Severe Cold and Flu, in the listed name, the word “severe” is spelled as “sever.”

Therefore, your 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) of the FD&C Act, 21 U.S.C. 331(p). In addition, Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-4210, is not properly listed with FDA causing it to be a misbranded drug under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education. We note that this warning letter only addresses registration and listing issues associated with your product.

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at eDRLS@fda.hhs.gov for further assistance. Include the case identification numbers (2851), (CMS 654751) on all correspondence.

Sincerely,
/S/
James Flahive, J.D.
Deputy Director
Office of Unapproved Drugs and Labeling Compliance
Signed on behalf of:

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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1 On December 30, 2024, we sent your firm a drug listing deficiency letter describing the observed listing deficiencies in the information submitted for the drug listing of Maximum Strength Nighttime Sever Cold and Flu, NDC 68210-
4210. On February 13, 2025, we sent your firm a data removal notification informing you of a data removal action. As stated in that email, the continued deficiencies resulted in your product’s data removal from FDA’s National Drug Code Directory. FDA sends listing deficiency letters and data removal notifications to the contact person found in the labeler code SPL submitted to FDA. If this information has changed, it is your responsibility to update your listing(s) within 30 days of any change, under 21 CFR 207.33(c).

2 An Untitled Letter was sent to Spirit Pharmaceuticals LLC, at 225 Lincoln Highway Suite #205, Fairless Hills, PA 19030, addressed to Kunjal Joshi noting the error in the listing submission. No response from the firm was received and the submission error remains. It appears that Spirit is now known as Prodose, Inc.