FDA EIR - Unknown Company - July 23, 2020

An FDA Summary Report, dated October 27, 2020, detailed findings from the analysis of a domestic pharmaceutical product, Finasteride Plus 1.25 mg capsules (Lot # 02-27-2020:04@11). The sample collection, initiated on June 4, 2020, by the New York District Office, stemmed from a critical follow-up to a consumer complaint involving an adverse reaction. Laboratory analysis, completed on July 23, 2020, uncovered significant issues. The primary violation was the presence of Minoxidil, an undeclared active pharmaceutical ingredient, found at an average concentration of approximately 127-131 mg per capsule. Furthermore, the label claim for the declared active ingredient, Finasteride, was significantly inaccurate. Initial testing indicated 3.44 mg per capsule, representing 274.8% of the 1.25 mg label claim. A subsequent check analysis confirmed an elevated Finasteride content of 1.50 mg per capsule, or 120% of the label claim. While Zinc Gluconate content was near its label claim (92.37%), the other discrepancies are critical. These findings, classified as 'Adverse Findings' by the collecting district, indicate a serious deviation from regulatory requirements for drug product formulation and labeling. The U.S. Food and Drug Administration's framework mandates accurate ingredient declarations and precise dosage control to ensure patient safety and product efficacy. The detected issues could pose significant health risks, particularly given the consumer complaint that initiated the investigation. Such adverse findings typically necessitate corrective actions from the responsible manufacturer to achieve compliance.