FDA WARNING_LETTER - Breckenridge Pharmaceutical, Inc.

The FDA issued a Warning Letter to Breckenridge Pharmaceutical, Inc. concerning drug products manufactured by Provident, specifically Trital SR Tablets and Migrazone Capsules, following a prior (b)(4) to Provident. The FDA determined these products are "new drugs" lacking approved applications, as required by the Federal Food, Drug and Cosmetic Act. The introduction or delivery of these unapproved new drugs into interstate commerce violates sections 301(a) and (d) of the Act [21 U.S.C. 331(a) and (d)]. Additionally, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because their labeling fails to bear adequate directions for use, as they are intended for conditions not amenable to self-diagnosis (21 C.F.R. § 201.5). Furthermore, these drug products are adulterated under 21 U.S.C. 351(a)(2)(B). Breckenridge Pharmaceutical is responsible for investigating and correcting these violations, which are not limited to Provident-manufactured products. The firm must respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to promptly correct these serious violations may lead to legal actions, including seizure and injunction, and could impact future federal contracts.