Iso-Tex Diagnostics, Inc. – FDA Warning Letter

On March 2, 2015, the FDA issued a Warning Letter to Iso-Tex Diagnostics, Inc. regarding its manufacturing and marketing of Volumex (Albumin Iodinated I-131 Serum) 0.025 mCi/mL. The FDA stated that this product is an unapproved new drug and is misbranded, violating the Federal Food, Drug, and Cosmetic Act.

The FDA has approved Megatope (Albumin Iodinated I-131 Serum) 1 mCi/mL under NDA 017837, but Volumex 0.025 mCi/mL has a different strength and lacks an approved application or supplemental application. The product's labeling indicates its use for "determinations of total blood and plasma volumes and in protein turnover studies," classifying it as a drug under Section 201(g)(1)(B) and (C) of the Act. As a "new drug" under Section 201(p), it is not generally recognized as safe and effective for its labeled uses.

Introducing or delivering a new drug into interstate commerce without an FDA-approved application violates Sections 301(d) and 505(a) of the Act. Furthermore, as a prescription drug under Section 503(b)(1), Volumex lacks adequate directions for lay use, making it misbranded under Section 50