Patient Safety

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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CDC, FDA investigate harmful counterfeit Botox

by Veronica Salib

On April 15, 2024, the United States Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) launched an investigation into harmful reactions caused by counterfeit or...

CRN launches new labeling guidelines for melatonin supplements

by Veronica Salib

On April 15, 2024, the Council for Responsible Nutrition (CRN), one of the most prominent trade associations for the dietary supplements industry, issued a statement highlighting new labeling...

EPA finalizes chemical plant clean air standards

by Veronica Salib

On April 9, 2024, the United States Environmental Protection Agency (EPA) finalized a ruling to regulate toxic air pollution from chemical plants. The finalized ruling focuses on two primary...

Roughly 65% of bandages on the market contain forever chemicals

by Veronica Salib

Earlier this month, Environmental Health News partnered with Mamavation, a consumer watchdog site, to analyze the use of forever chemicals in bandages, including the popular Band-Aid brand. The study...

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...

Developing Quality Assurance Standards for Biologics, Biosimilars

by Veronica Salib

Biologics and biosimilars are a rapidly growing sector of the biopharmaceutical industry. However, as the field grows, multiple challenges arise in the manufacturing and quality assurance guidelines for biologics and...

Advancing Sterility Assurance Through Environmental Monitoring

by Alivia Kaylor

In the pharmaceutical industry, ensuring the safety and efficacy of drugs is of utmost importance. Quality assurance is critical in maintaining high standards for pharmaceutical products, and one essential aspect of quality assurance is...

Mislabeled Packaging Results in Recalled ADHD Medication

by Veronica Salib

On January 24, 2024, Azurity Pharmaceuticals sent an announcement to the United States FDA recalling Zenzedi, a brand name for 30 mg dextroamphetamine sulfate tablets, for mislabeled packaging. The...

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 Investigates the Safety of GLP-1 Weight Loss Drugs

by Veronica Salib

Yesterday, on January 11, 2024, the United States FDA issued a drug safety communication updating the public on an ongoing investigation of glucagon-like peptide-1 receptor agonists. The administration...

FDA Recalls 3 IV Drugs from Leiters Health for Potential Superpotency

by Veronica Salib

On January 5, 2024, the United States FDA published an announcement detailing a voluntary recall of multiple intravenous (IV) drugs manufactured by Leiters Health. The release notes that 33 lots of IV...

Online Pharmacies Under Scrutiny for Lax Safety Checks, Endangering Patients

by Alivia Kaylor

In a groundbreaking investigation, the BBC uncovered a concerning trend in the online pharmaceutical industry, where prescription-only medicines are sold without adequate checks. The report exposes a...

Navigating the Complex Terrain of Influenza Vaccine Strain Selection

by Alivia Kaylor

In the battle against influenza, the annual selection of vaccine strains is a crucial step in ensuring the effectiveness of flu vaccines. The process involves an intricate dance of global surveillance, scientific analysis, and regulatory...

FDA Publishes Drug Safety Communication for Antiseizure Drugs

by Veronica Salib

Earlier this week, the United States Food and Drug Administration (FDA) published a drug safety communication warning patients about potentially life-threatening side effects linked to levetiracetam...

26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

by Veronica Salib

On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health,...

FDA Issues Warning About Probiotics Sold for Preterm Infants

by Veronica Salib

On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to...

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...

Antifungal Therapeutic Drug Monitoring Are Rates Lower Than Use Rates

by Veronica Salib

According to the results of an article published in Open Forum Infectious Diseases, infectious disease specialists are not monitoring antifungal prescriptions at the same rates they are prescribing...

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

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