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Warning Letter

October 19, 2022

RE: WL 2277

Dear Ms. Horton:

The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, “Mucus Relief DM, NDC 11822-7224." Our review revealed that there is a discrepancy in the listed active ingredients between the submitted labeling and the electronic listing file since the electronic listing file includes an extra active ingredient, phenylephrine hcl, that the label does not.

As such, your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below. We note that FDA previously sent you and your firm two letters on this same subject, one on December 6, 2021, notifying you of listing deficiencies, and a subsequent listing removal notification on January 20, 2022. As stated in the removal notification letter, the continued deficiencies resulted in your products’ removal from FDA’s Online NDC Directory.

Section 510(j) of the FD&C Act and 21 CFR 207 outline drug registration and listing requirements. Under section 510(j)(1)(C), 21 U.S.C. 360, a firm must include in the listing, among other requirements, “the name and quantity of each active pharmaceutical ingredient in the listed drug.” However, the names of the active ingredients listed in the electronic listing file for Mucus Relief DM, NDC 11822-7224, do not match the names of the active ingredients found on the copy of the labeling provided with the listing submission. Specifically, the names of active ingredients found in the electronic copy include dextromethorphan hydrobromide, guaifenesin, and phenylephrine hcl, while the labeling only includes dextromethorphan hydrobromide and guaifenesin.

Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, which is a prohibited act under section 301(p), 21 U.S.C. 360(j) and 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 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 products. It 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 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. 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 number of 2277 on all correspondence.

Sincerely,
/S/

Carolyn E. Becker, J.D.
Director, Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration