Unisource, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Unisource, Inc. regarding unapproved and misbranded new drug products, specifically Dicel DM Suspension and Dicel Suspension. These products, containing chlorpheniramine tannate, dextromethorphan tannate, and pseudoephedrine tannate, are classified as "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective.

The primary violation is the introduction of these new drugs into interstate commerce without FDA-approved applications, which contravenes sections 301(d) and 505(a) of the Act. Additionally, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layman, as they are intended for conditions requiring medical practitioner diagnosis and treatment. The letter also states that the drug products are adulterated under 21 U.S.C. 351(a)(2)(B).

Unisource, Inc. is required to promptly investigate and correct these violations, prevent recurrence, and ensure compliance with federal law and FDA regulations. Failure to do so may result in legal action, including seizure and injunction. The company must respond in writing within fifteen working days, detailing corrective actions, prevention steps, and supporting documentation. If marketing has ceased, the response should indicate the reasons and date.