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Recall occur as a consequence of the safety concerns over a manufacturing defect in a product that may harm its user. Due to their deficient quality, security or effectiveness, medicinal products are accused of being possibly dangerous to customers and may be subject to recall. A recall is defined as the process of recovering. A pharmaceutical product from the distribution chain due to product deficiencies, complaints of serious adverse reactions or corners that the product is or may be defective. The objective of study is to help identify the significance of the recall action and classification and focused on the prospective danger of the patient / consumer defect and, to understand the recall procedure in United Kingdom and Australia. The recall may either be conducted by the license holder or the manufacturer, or and the wholesale dealer. The evaluation should consist of checking the efficacy of the recall and investigating the justification for the recall as well as the remedial measures adopted to avoid the occurrence of the issue. The present work highlights the comparison of the recall procedure between United Kingdom and Australia.


Regulatory authority Classification Manufacturer Wholesaler Risk

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How to Cite
Nandhini B, Balamurlidhara V, Aniket Anant Gulumkar, & Sridhar S. (2020). Drug recall procedure in United Kingdom and Australia: a regulatory overview. International Journal of Research in Pharmaceutical Sciences, 11(2), 1457-1466.