Do you think a recall procedure is really needed at the API manufacturer considering that it will be the API customer accepting or rejecting that API, and in case of rejection, sending the material back to the manufacturer? The real recall will be in charge of the pharma transformer that will put the drug product into the market.
You may uncover some day, a very low-level trace impurity that didn’t fail anything that has
caused major health problems, and you have to have a recall. You do need to have a recall
procedure.
