Injectable products contaminated with visible particulates, such as glass or rubber, can cause severe complications including inflammation, tissue damage or embolic events. The pharmaceutical industry must prioritize improving inspection practices and aligning with FDA guidance to prevent such contamination and ensure patient safety.
Manual visual inspection is essential for detecting particles in injectable pharmaceutical products. By enhancing inspector proficiency, optimizing inspection conditions, and utilizing advanced tools, manufacturers can significantly improve particle detectability and ensure product quality and patient safety.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Par Pharmaceutical, Inc. has voluntarily recalled one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product was recalled due to the potential for the presence of silicone particulates in the product solution.
The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection.
Ensuring the safety and quality of injectable drugs requires rigorous standards in facility design, equipment selection, and inspection processes....
Manual visual inspection plays a crucial role in upholding product integrity, patient safety, and regulatory compliance. Let's dive into...
Injectable products are a type of pharmaceutical formulation designed to be administered directly into the body through a needle....
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