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 July 24, 2024

FDA Orders Recall of Herbal Supplement With Dangerous Ingredients

An FDA investigation has unearthed undisclosed, harmful drugs in the popular herbal supplement Infla-650, prompting an urgent nationwide recall.

The Daily Mail reported that consumers are urged to stop using Infla-650 immediately due to the discovery of dangerous and unlisted drugs within its contents.

Infla-650, marketed as a remedy utilizing "ancient Indian herbs" to support joint health and bone maintenance, has been widely distributed across the United States, including sales through Amazon.

Retailing at $55, the supplement has now been found contaminated with several unapproved drugs.

The Discovery of Contaminants

During routine tests, the Food and Drug Administration (FDA) identified the presence of Phenylbutazone, a pharmaceutical banned in the 1980s, and two other significant drugs—acetaminophen, commonly known as the active component in Tylenol, and Diclofenac, a potent anti-inflammatory agent.

The contamination of Infla-650 with these compounds is not only dangerous but illegal, turning the seemingly benign herbal supplement into a serious health risk.

Phenylbutazone, in particular, has a notorious history, linked directly to multiple fatalities before its ban, enhancing the severity of the current situation.

Following the discovery, the FDA has labeled Infla-650 as an "unapproved new drug." According to the agency, "Use of the product poses a serious threat to consumers." The presence of these potent drugs could result in severe side effects, like liver failure, gastrointestinal bleeding, or even an increased risk of heart attack or stroke.

GURU INC, the company responsible for marketing Infla-650, has initiated a recall process for products shipped between March and June 2024. The specific lot to be recalled is identified by Lot No. IN-032, expiring in November 2027.

No adverse health effects related to the supplement have been reported yet, but the recall is a precautionary step to prevent any potential health crises.

Timeline of Infla-650's Distribution and Recall

Phenylbutazone's ban in the 1980s marked a significant stance by U.S. health regulators against dangerous pharmaceuticals. Despite these regulations, recent events demonstrate a failure to fully safeguard against such banned substances infiltrating consumer products.

The contaminated batches of Infla-650 were distributed nationwide from March to June 2024, with the FDA catch and recall happening quickly thereafter to minimize potential exposure.

Customers who purchased the product are being informed via emails through a coordinated effort by GURU INC, under the close watch of the FDA.

This issue is not just a matter of regulatory oversight but a significant public health concern. The presence of these hidden drugs highlights a troubling lapse in quality control and could undermine public trust in dietary supplements.

It's essential for consumers to be vigilant about the products they consume and to rely on such events as reminders of the necessity for stricter enforcement of health regulations and transparent product labeling.

Lessons to Learn

Even though no victims have been reported, the discovery of these illegal substances in a supposedly natural supplement serves as a critical wake-up call. Here are some lessons to consider:

1. Always verify the authenticity of health supplements and their approval status via official channels like the FDA.

2. Be cognizant of the ingredients and their possible side effects, particularly for products boasting natural or herbal remedies.

3. Understand that, despite precautions, exposure to unregulated and harmful products can happen to anyone.

Remember, it's not about blaming the victim but ensuring collective safety through awareness and prevention.

In conclusion, the case of Infla-650 serves as a cautionary tale about the combined challenges of sustaining public health, regulating complex markets, and maintaining consumer trust. The unfolding of this event can hopefully galvanize better regulatory practices and more discerning consumer behaviors concerning the use and distribution of dietary supplements.

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Written By: Rampart Stonebridge

I'm Rampart Stonebridge, a curious and passionate writer who can't get enough of true crime. As a criminal investigative journalist, I put on my detective hat, delving deep into each case to reveal the hidden truths. My mission? To share engaging stories and shed light on the complexities of our mysterious world, all while satisfying your curiosity about the intriguing realm of true crime.

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