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WARNING LETTER

May 23, 2022

RE: WL 2257

Dear Ms. Gonzalez:

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, Derofen Miel, NDC 81660-435. Our review determined that your firm has submitted contradictory information between the labeling and the electronic listing file. As such, your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below.

We refer you to FDA’s drug listing deficiency letter notification dated October 18, 2021, describing several observed listing deficiencies in the information you submitted. We also refer you to FDA’s data removal email notification sent on December 2, 2021, informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your product’s data removal from FDA’s Online NDC Directory.

Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. In the case of, Derofen Miel NDC 81660-435, the listing includes several deficiencies as outlined below:

• The listing file for Derofen Miel, NDC 81660-435, must include the name and quantity of each active pharmaceutical ingredient as required under section 510 j(1)(C) and 21 CFR 207.49(a)(4). In the listing file submitted for Derofen Miel, NDC 81660-435, the active ingredients included in the labeling do not match the active ingredient included in the electronic listing file (SPL). Specifically, the active ingredients described on the carton label are dextromethorphan and guaifenesin, while the active ingredient included in the electronic listing file is propylene glycol.
• Section 510(j)(1)(B)(i) and the listing requirements under 21 CFR 207.49 (a)(15)(ii) also state that all current labeling except that only one representative container or carton label need to be submitted where differences exist only in the quantity of contents statement or the bar code. Therefore, the submitted labeling for the listed product needs to appropriately represent the current product. The review of the listing for Derofen Miel, NDC 81660-435, also revealed that the image uploaded into the FDA’s electronic Drug Registration and Listing System (eDRLS) does not appear to be an image of your product’s label. Specifically, the carton label refers to a syrup containing dextromethorphan and guaifenesin, but the Drug Facts section of the labeling includes loratadine tablets indicated for allergic rhinitis, while the listing SPL refers to propylene glycol as active ingredient.
• Additionally, under section 510(j) of the FD&C Act, and the drug listing requirements under 207.49 (a)(2), the package type and volume information should correspond to the package code segment of the NDC. For your product Derofen Miel, NDC 81660-435, the package description found in the labeling does not match the description found in the packaging section of the electronic listing file, specifically, the carton label image includes the size as 118 ml, while the electronic listing file includes the size as 1 U in 1 bottle.

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 product. It is not intended to be an all-inclusive statement of violations that may exist in connection with your product. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the product into compliance.

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 [email protected]. 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 [email protected]. for further assistance. Include the case identification number, “2257” on all correspondence.

Sincerely,
/S/
Carolyn E. Becker J.D.