Public Health Service Food and Drug Administration
Silver Spring, MD 20993
RETURN RECEIPT REQUESTED
March 31, 2015
Rebel Distributors Corp.
3607 Old Conejo Rd.
Thousand Oaks, CA 91320
Dear Chris Baurer:
The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for Cimetidine 300 mg tablet (NDC 21695-531), Cimetidine 400 mg tablet (NDC 21695-532), Digoxin 0.125 mg tablet (NDC 21695-678) and Hydrocodone Barbiturate and Acetaminophen 10mg/ 500 mg tablet (NDC 21695-273). Our review revealed the listing for each of these products is inaccurate. Prompt action must be taken to correct these deficiencies.
Section 510 (j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outlines the requirements for registration and listing of drug products. In the case of drug products such as Cimetidine 300 mg tablet (NDC 21695-531), Cimetidine 400 mg tablet (NDC 21695-532), Digoxin 0.125 mg tablet (NDC 21695-678) or Hydrocodone Barbiturate and Acetaminophen 10mg/ 500 mg tablet (NDC 21695-273), the listing must include a reference to the authority for marketing such a drug. Among other responsibilities, the listing must include the new or abbreviated new drug application number.
A review of the listing for Cimetidine 300 mg tablet (NDC 21695-531), Cimetidine 400 mg tablet (NDC 21695-532), Digoxin 0.125 mg tablet (NDC 21695-678) and Hydrocodone Barbiturate and Acetaminophen 10mg/ 500 mg tablet (NDC 21695-273) reveals that these products’ listings do not list the correct application number. The submitted listing information for each of these includes a number that does not refer to the listed products.
Your firm failed to fulfill 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, your firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act. Introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) [21 U.S.C. 352(o) and 331(a)].
This information must be corrected to ensure its accuracy. Information from your firm’s registration and product listing are accessible not only to FDA, but to other interested parties, including consumers. It is imperative that the information submitted by your firm reflect timely and accurate information. If these products appear on the online NDC Directory, they will be removed from public viewing on the same date this letter is issued to you, until the required corrections are made. This is an effort to maintain a correct and accurate database in order to protect and promote the public health.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete these corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your reply should be sent to:
Leyla Rahjou-Esfandiary, Pharm.D.
Pharmacist, Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Mail Stop HFD-300
Bldg 51/ Room 2262
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact email@example.com. Include the case identification number of Case_ID_423611 on all correspondence.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations found in your firm’s registration and product listing. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.