Their terminology referencing Investigational new drug may in fact be a general or broad term given to the drug plus placebo. I don't think that it can be taken literally.
From PR: "A subsequent review of information has determined that the source of these discrepancies appear to have been associated with the independent third-party contracted to code and distribute investigational drug product."
From the FDA (CFR 21 part 312 - laws governing IND applications to use product in human trials): "Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational drug" and "investigational new drug" are deemed to be synonymous for purposes of this part."
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