by Dr. Yashashwini Reddy | Sep 26, 2025
📌 Case Study: Sun Pharma / Caraco (US) – Recalls due to Contamination and CGMP Non-Compliance Background Caraco Pharmaceutical Laboratories, a US-based generic manufacturer and subsidiary of Sun Pharma, came under FDA scrutiny due to multiple quality issues. As one of...
by Dr. Yashashwini Reddy | Sep 24, 2025
Case Study: Tylenol Cyanide Crisis (1982) Background Johnson & Johnson’s Tylenol was a leading over-the-counter (OTC) pain reliever in the U.S. In 1982, an incident shocked the pharmaceutical industry and the public health system, raising questions about drug...
by Dr. Yashashwini Reddy | Sep 24, 2025
📌 Case Study: Heparin Contamination (2008) Background Heparin is a widely used anticoagulant, often derived from porcine intestinal mucosa. In 2007–2008, reports of severe adverse reactions and deaths were linked to contaminated heparin products, especially in the...
by Dr. Yashashwini Reddy | Sep 24, 2025
Case Study: Valsartan Recall (2018) Background Valsartan is an angiotensin II receptor blocker (ARB) widely prescribed for hypertension and heart failure. In July 2018, several regulatory agencies, including the USFDA, EMA, and Health Canada, announced recalls of...
by Dr. Yashashwini Reddy | Sep 24, 2025
Case Study: Gilead’s Remdesivir during COVID-19 Pandemic Background Remdesivir is an antiviral originally developed by Gilead Sciences for Ebola virus infection. During the COVID-19 pandemic (2020), early in-vitro and clinical data suggested that Remdesivir could...
