{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,12]],"date-time":"2026-07-12T06:18:01Z","timestamp":1783837081877,"version":"3.55.0"},"reference-count":40,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T00:00:00Z","timestamp":1764547200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Drug Safety"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Drug recalls safeguard patients from potentially harmful existing pharmaceutical products in the market due to safety concerns or manufacturing issues.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To analyze the drug recall patterns, frequencies, and causes based on the publicly available data from the Nepalese Drug Regulatory Authority, Department of Drug Administration (DDA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>A 2-year retrospective secondary analysis was conducted based on drug recalls in Nepal, which is available from the official website of DDA, Nepal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The substandard drug recalls data from April 17th, 2023 to May 14th, 2025 were included in the study from which information were extracted across various domains, including the drug name, dosage forms, manufacturing and expiry date, reasons for the recall, and recall date whereas, inclusion of falsified medicines and information regarding the \u201cspecial permission,\u201d \u201cnews &amp; updates,\u201d and \u201cnotices\u201d sections within the DDA website were excluded from the studies to ensure only drug recalls were incorporated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The study showed that 50 recalls were made over the 2\u2009year period. The majority of the recalled drugs were antibiotics (16%). The most common reasons for drug recalls were assay failure (34%) and non-compliance with standards set out by the Indian Pharmacopoeia-2022 (40%), followed by United States Pharmacopoeia-2022 (28%). Oral formulations (74%) were most commonly recalled, out of which tablets (32%), suspensions (16%), and syrups (12%) were recalled in greater frequencies among all the recall notices. Most recalls were made from domestic pharmaceutical companies (84%). The majority of the drugs (34%) were recalled after 15\u2009months of the finished product being in the market, whereas only 26% were recalled within the first 5\u2009months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>A robust and continuous evaluation of drug recalls by regulatory authorities can help reduce their frequency, lessen their impact on the healthcare system, and improve overall drug safety.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420986251398725","type":"journal-article","created":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T13:29:31Z","timestamp":1764854971000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Drug recall, its frequencies and conclusion: a retrospective secondary analysis involving 2-year publicly available data from Nepal"],"prefix":"10.1177","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-2014-4339","authenticated-orcid":false,"given":"Sachita","family":"Barma","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Madan Bhandari Academy of Health Sciences, Hetauda, Bagmati Province, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1952-642X","authenticated-orcid":false,"given":"Nabin","family":"Pathak","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Madan Bhandari Academy of Health Sciences, Hetauda, Bagmati Province, Nepal"},{"name":"Drug Information Unit and Pharmacovigilance Cell, Department of Pharmacy, Hetauda Hospital, Madan Bhandari Academy of Health Sciences, Hetauda, Bagmati Province, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6176-0255","authenticated-orcid":false,"given":"Shreya","family":"Dhungana","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, National Model College for Advanced Learning, Tribhuvan University, Kathmandu, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4782-5013","authenticated-orcid":false,"given":"Prabhat Kumar","family":"Jha","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Madan Bhandari Academy of Health Sciences, Hetauda, Bagmati Province, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9174-7120","authenticated-orcid":false,"given":"Sunil","family":"Shrestha","sequence":"additional","affiliation":[{"name":"Department of Research and Academics, Kathmandu Cancer Center, Bhaktapur, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,12,4]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2024.103993"},{"key":"e_1_3_4_3_2","unstructured":"USFDA. 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Department of Drug Administration (DDA) Ministry of Health and Population Government of Nepal https:\/\/dda.gov.np\/content\/3\/drugs-act-2035\u2014-english\/ (2025 accessed 10 July 2025)."},{"key":"e_1_3_4_20_2","unstructured":"Regarding providing opinions and suggestions on the draft bill to make provisions regarding medicines and health supplies Ministry of Health & Population of Nepal https:\/\/mohp.gov.np\/content\/230\/the-draft-urgency-of-the-bill-of\/ (2025 accessed 15 July 2025)."},{"key":"e_1_3_4_21_2","unstructured":"Recalls & Drug Alerts Department of Drug Administration https:\/\/dda.gov.np\/category\/recalls-drug-alert\/ (2025 accessed 4 September 2025)."},{"key":"e_1_3_4_22_2","article-title":"The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies","volume":"4","author":"Elm E","year":"2007","unstructured":"Elm E, von Altman DG, Egger M, et al. 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