REGULATORY INTELLIGENCE·Warning Letter
TRIOVA PHARMACEUTICALS LLC Estriol Recall: Organic Impurity Failures Expose API Quality Control Gaps
TRIOVA PHARMACEUTICALS LLC initiated a Class II nationwide recall of Estriol USP Micronized 5 G due to failed organic impurities and degradation specifications. This event, now terminated, highlights critical quality control vulnerabilities in API supply chains. Procurement and regulatory teams must reinforce supplier qualification and analytical testing protocols to mitigate risks from out-of-specification raw materials, safeguarding product integrity and patient safety.
90-Day Activity