Rebel Distributors Corp – FDA Warning Letter

The FDA issued a Warning Letter to Rebel Distributors Corp. on March 31, 2015, following a review of their drug product listing information. The review identified inaccuracies in the listings 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).

Specifically, the listings for these products failed to include the correct new or abbreviated new drug application numbers, as required by Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 207.25(b)(2). This constitutes a prohibited act under Section 301(p) of the FD&C Act and also misbrands the products under Section 502(o), making their introduction into interstate commerce a prohibited act under Section 301(a).

As a consequence, if these products are currently listed on the online NDC Directory, they will be removed from public viewing until the required corrections are made. Rebel Distributors Corp. is required to notify the FDA in