FDA Compliance

Stop Clopez Corp voluntarily recalls herbal dietary supplement

April 26, 2024 - On April 23, 2024, the United States FDA published a voluntary recall from Stop Clopex Corp regarding its Schwinnng capsules. According to the recall, the product was found to contain Nortadalafil, an active drug ingredient, during an FDA analysis. Dietary supplements are only loosely regulated across the United States. Unlike pharmaceutical...

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FDA issues warning letters for unapproved topical pain relief products

by Veronica Salib

On March 26, 2024, the United States FDA published a press release informing consumers of six warning letters sent to companies regarding unauthorized topical pain relief products. The following...

Evaluating the Series of Infant Formula Recalls in the US

by Veronica Salib

Infant formula plays a critical role in pediatric healthcare, providing an alternate route for nutrition in babies who do not breastfeed or may need more nutrients than what is provided in breast milk. Although many people, including...

FDA Announces Kilitch Healthcare India Eyedrop Recall

by Veronica Salib

On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through...

FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

by Veronica Salib

On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven...

What to Know About the 2023 Eyedrop Recalls, Understanding the Risks

by Veronica Salib

On February 2, 2023, the first of three eyedrops in the United States were recalled voluntarily after multiple reports of illness associated with the drops were reported to the CDC. Since then, two additional eye drops in the US...

8 Steps to Negotiating Successful Pharmaceutical Partnerships

by Alivia Kaylor

The pharmaceutical industry is a dynamic and highly regulated sector that offers immense potential for healthcare technology companies seeking collaborative opportunities. By forging strategic partnerships with pharmaceutical companies,...

Ensuring Drug Safety Through Regulatory Compliance

by Alivia Kaylor

In healthcare technology, the intersection of science and regulations is where innovation meets responsibility. Nowhere is this more evident than in the pharmaceutical industry, where drug safety is paramount. Regulatory compliance plays a...

A Look at California’s Newest Bans on Chemicals in Food

by Veronica Salib

On October 7, 2023, California Governor Gavin Newsom signed a bill prohibiting the manufacturing, sale, delivery, distribution, or carrying of food products for human consumption containing four presumably harmful chemicals: brominated...

Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) issued two warning letters to online vendors selling unauthorized versions of semaglutide and tirzepatide, active ingredients in...

FDA Updates Infant Formula Compliance Program

by Veronica Salib

To minimize the risk of contaminated infant formula, the United States Food and Drug Administration (FDA) updated its infant formula compliance program, announcing the changes on October 6, 2023. Last...

FDA Issues Guidance on Drug Development for Stimulant Use Disorders

by Veronica Salib

On October 4, 2023, the United States Food and Drug Administration (FDA) released a draft guidance titled Stimulant Use Disorders: Developing Drugs for Treatment. The recommendations suggest protocols...

FDA Issues Warning Letters for Marketing Unapproved Ophthalmic Drugs

by Veronica Salib

On September 12, 2023, the United States Food and Drug Administration (FDA) issued warning letters to eight companies, including Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc,...

FDA Issues 15 Warning Letters to Online Retailers Selling E-Cigarettes

by Veronica Salib

On August 23, 2023, the United States Food and Drug Administration distributed 15 warning letters to online retailers selling or distributing illegal and unauthorized e-cigarettes that appeal to...

Red Cross Adopts FDA’s Blood Donation Policies to Expand Eligibility

by Veronica Salib

On August 7, 2023, the American National Red Cross announced that it would adopt the United States Food and Drug Administration’s new blood donation protocols. This shift will widen donor...

A Melatonin Study Highlights a Lack of Supplement Regulation

by Veronica Salib

JAMA recently published a research letter highlighting the lack of supplement regulation by comparing the amount of melatonin and CBD in varying brands of melatonin gummies. The researchers determined...

How to Properly Dispose of Unused Drugs, Understanding Key Roles

by Veronica Salib

Unused medications pose a significant threat to healthcare, considering the impacts of improper disposal and drug misuse. Over-the-counter (OTC) and prescription medications that are expired or no longer needed by the intended patient...

FDA Details Manufacturing Conditions That Led to Eye Drop Recall

by Hayden Schmidt

After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...

Meteoric Rise of Weight-Loss Drug Wegovy Brings Pushback to Novo Nordisk

by Hayden Schmidt

In June of 2021, the FDA approved Novo Nordisk’s Wegovy to aid in weight management in overweight adults with weight-related chronic conditions like high blood pressure, type 2 diabetes, or high...

Understanding Pharmaceutical Recalls, Key Players, and Their Roles

by Veronica Salib

Like any industry, recalls in the pharmaceutical industry are complex and expensive. However, as an added concern, pharmaceutical recalls have the potential to alter short and long-term health outcomes. Understanding the recall process for...

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