Product Patrolling: Learning Recall execution Strategies through Case studies

  • Ankita Bobhate smt. kishoritai bhoyar college of pharmacy, kamptee.
  • Piyush N. Bajare
  • Vinita V. Kale
  • Suankit A. Harane
  • Milind J. Umekar


There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company’s discovery, customer’s complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall.This abstract explores the critical aspects of pharmaceutical drug product recalls, focusing on their classification, recall levels, and effective recall strategies. The pharmaceutical industry faces challenges in ensuring the safety and efficacy of drug products, necessitating a robust recall framework. We delve into the classification of recalls, ranging from voluntary actions to mandated recalls, emphasizing the importance of prompt and transparent communication. Recall levels, categorized based on the severity of potential health risks, are examined to provide a comprehensive understanding of the regulatory landscape. Furthermore, this abstract highlights innovative recall strategies, encompassing technology-driven traceability, stakeholder collaboration, and crisis communication. By addressing these key elements, this research contributes to enhancing the efficiency and reliability of drug product recall processes, ultimately safeguarding public health and bolstering industry resilience.

Keywords: Recall information, FDA, recall strategy, recall levels, Voluntary recall, Investigation, Incident, Recall Decision, Drugs & Cosmetics Act.


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How to Cite
Bobhate, A., P. N. Bajare, V. V. Kale, S. A. Harane, and M. J. Umekar. “Product Patrolling: Learning Recall Execution Strategies through Case Studies”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 93-101, doi:10.22270/ijdra.v11i4.641.

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