REGULATORY INTELLIGENCE·Warning Letter
FDA Class II Recall: NBMA Impurity in Losartan Potassium API Impacts Golden State Medical Supply
Golden State Medical Supply Inc. faced a Class II FDA recall for Losartan Potassium Tablets due to N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) impurity in the API. This event underscores critical supply chain vulnerabilities in API quality control, demanding enhanced due diligence from procurement and stringent CGMP adherence to mitigate regulatory and patient safety risks across the pharmaceutical industry.
90-Day Activity