The FDA hit Canadian drug distributor CanaRx with a warning letter, citing the company for supplying unapproved versions of FDA-cleared drugs.

The warning letter, based on a long-term review of the company’s practices, took issue with the company’s substitution of FDA-approved drugs with unapproved drugs, which it supplied to the employees of its clients — employers in both the public and private sector.

Specifically, a note on the invoice template the company uses showed that approved drugs were being substituted with potentially unsafe ones. The disclaimer — “depending on your country, our medications may appear to be different in size, shape or color” — showed that the company “designed its business to operate in a manner that substitutes the FDA-approved drugs prescribed by the U.S. healthcare provider with unapproved drugs,” the warning letter said.