MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug

… MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain … water, dizziness and low blood pressure. The product is a compounded drug for hair loss and is packaged in orange …

MasterPharm LLC - 612401 - 07/19/2021

… are implemented and, on July 2, 2020, voluntarily recalled compounded products within expiry that were prepared by … the Federal Food, Drug, and Cosmetic Act (FDCA). A. Compounded Drug Products Under the FDCA Section 503A of the … adverse events experienced by 74 patients associated with Finasteride Plus capsules produced by your firm that were …

July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… FDA is evaluating the need for regulatory action. Finasteride Plus 1.25mg capsules (compounded drug)   Minoxidil (compounded drug) Cardiac effects related to undeclared or …

2023 Compounding Quality Center of Excellence Conference: Incident Management

… all serious adverse drug experiences associated with their compounded prescription drug products. 7 Outsourcing … events, drug quality issues, or other issues related to compounded drugs that pose a risk to public health. • First … adverse events (SAEs) reports associated with one lot of Finasteride Plus o This specific lot contain undeclared …

Rx Unlimited Pharmacy, North Hills, CA. 483 Issued 10/21/2022

… compounding area. For example, you dispensed the following compounded drng products: - BI-EST (80:20) 2.G … as an ingredient. For example you dispensed the following compounded diug products : -Misoprostol … Suspens10 • n (Lot# 09212022@J lbH• BUD:10/01/2022) -Finasteride Foam 0.2% (Lot# 09262022@JBUD: 10/26/2022) …

Hybrid Pharma LLC, Deerfield Beach, FL. 483 issued 09/03/2021

… less thaa units). For example, the following products were compounded and no finge1tip or sleeve samples were collected: … as an outsourcing facility identifying the dr·ugs compounded during the previous six month period. … 0.1 % topical solution • Minoxidil 5%, tretinoin 0.01 %, finasteride 2.5% topical solution • Naltrexone 2 mg capsules …

Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

… 2 A condition of section 503B of the FD&C Act is that the compounded drug product is not essentially a copy of one or … in section 503B, see FDA’s guidance for industry “Compounded Drug Products That Are Essentially Copies of … • Famotidine** • Fentanyl Citrate** • Ferric subsulfate • Finasteride** • Fluconazole** Updated May 20, 2024 4 • …