FDA Warns Two Repackaging Companies Of Failure to Fulfill Drug Listing Obligations

The Food and Drug Administration told RemedyRepack Inc. and Rebel Distributors Corp. that they haven’t fulfilled their drug listing obligations, according to warning letters posted April 21 on the FDA’s website.

Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) outlines requirements for the registration and listing of drugs, the agency said.

In a letter to RemedyRepack, which is based in Indiana, Pa., the agency said the company’s listing information provided for colchicine tablets is inaccurate because it doesn’t include the correct application number. “The submitted listing information includes a number that does not refer to the listed ...