{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:34:39Z","timestamp":1791909279329,"version":"4.3.4"},"reference-count":176,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2025,6,23]],"date-time":"2025-06-23T00:00:00Z","timestamp":1750636800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Medicinal products available on the market should be characterised by therapeutic efficacy, high quality, and safety for patients. They must either be sterile or comply with the appropriate pharmacopoeial microbiological purity requirements. Pharmacopoeial monographs related to microbiological tests of drug quality were also referenced. Despite stringent regulations governing pharmaceutical production, irregularities in the microbiological quality of drugs still occur. These are monitored by relevant agencies, which may order the recall of defective product batches from the market. However, in recent years, numerous cases of microbiological contamination in drugs and drug-related infections have been reported. Both isolated incidents and larger outbreaks or epidemics linked to contaminated medicines have been documented. Various microorganisms, including Gram-negative and Gram-positive bacteria, anaerobes, and yeast-like and mould fungi, have been identified in medicinal products or in patients affected by contaminated drugs. Ensuring the appropriate purity or sterility of pharmaceutical raw materials; maintaining cleanliness in the manufacturing environment, facilities, and equipment; and adhering to hygiene protocols and Good Manufacturing Practice regulations are essential for the production of safe and high-quality medicinal products. The aim of this study is to collect and compile information on the microbiological quality of drugs available on the market, with particular attention to identified irregularities, objectionable microorganisms isolated from medicinal products, and drug-related infections.<\/jats:p>","DOI":"10.3390\/ph18070946","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T10:44:41Z","timestamp":1750761881000},"page":"946","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Microbiological Contamination of Medicinal Products \u2014Is It a Significant Problem?"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3352-038X","authenticated-orcid":false,"given":"Stefan","family":"Tyski","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Microbiology and Laboratory Diagnostic, National Medicines Institute, 00-725 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Burza","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Microbiology and Laboratory Diagnostic, National Medicines Institute, 00-725 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5989-4462","authenticated-orcid":false,"given":"Agnieszka Ewa","family":"Laudy","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Microbiology and Bioanalysis, Medical University of Warsaw, 02-097 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,6,23]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1208\/s12249-017-0875-1","article-title":"Microbial stability of pharmaceutical and cosmetic products","volume":"19","author":"Dao","year":"2018","journal-title":"AAPS PharmSciTech"},{"key":"ref_2","first-page":"121","article-title":"The presence of microorganisms in some common excipients used in tablet formulation","volume":"63","author":"Obuekwe","year":"2006","journal-title":"Acta Pol. Pharm."},{"key":"ref_3","first-page":"217","article-title":"Distribution of bacterial contamination in non-sterile pharmaceutical materials and assessment of its risk to the health of the final consumers quantitatively","volume":"5","author":"Eissa","year":"2016","journal-title":"Beni-Suef Univ. J. Basic Appl. Sci."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"102064","DOI":"10.1016\/j.clae.2023.102064","article-title":"Bacterial contamination of multi-use tear drops, gels, and ointments","volume":"46","author":"Yilmaz","year":"2023","journal-title":"Contact Lens Anterior Eye"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1086\/502394","article-title":"Burkholderia cepacia infections associated with intrinsically contaminated ultrasound gel: The role of microbial degradation of parabens","volume":"25","author":"Hutchinson","year":"2004","journal-title":"Infect. Control Hosp. Epidemiol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"303","DOI":"10.1016\/j.jsps.2014.11.015","article-title":"Microbiological quality of non-sterile pharmaceutical products","volume":"23","author":"Ratajczak","year":"2015","journal-title":"Saudi Pharm. J."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"Ahmed, M.A.E.E., Abbas, H.S., and Kotakonda, M. (2024). Fungal diseases caused by serious contamination of pharmaceuticals and medical devices, and rapid fungal detection using nano-diagnostic tools: A Critical Review. Curr. Microbiol., 81.","DOI":"10.1007\/s00284-023-03506-7"},{"key":"ref_8","first-page":"4","article-title":"A review of fungal contamination in pharmaceutical products and phenotypic identification of contaminants by conventional methods","volume":"17","author":"Vijayakumar","year":"2012","journal-title":"Eur. J. Parent. Pharm. Sci."},{"key":"ref_9","first-page":"162","article-title":"Microbial contamination of eye drops","volume":"9","year":"2001","journal-title":"Cent. Eur. J. Public Health"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1067\/mic.2000.105286","article-title":"Enterobacter cloacae sepsis outbreak in a newborn unit caused by contaminated total parenteral nutrition solution","volume":"28","author":"Tresoldi","year":"2000","journal-title":"Am. J. Infect. Control."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"68","DOI":"10.11648\/j.pst.20210502.17","article-title":"A review on the microbial contamination in the non-sterile pharmaceutical products","volume":"5","author":"Murtaza","year":"2021","journal-title":"Pharm. Sci. Technol."},{"key":"ref_12","unstructured":"Gunter, J., and Pandey, V. (2025, February 24). BBC News: Waldemar Haffkine: The Vaccine Pioneer the World Forgot. Available online: https:\/\/www.bbc.com\/news\/world-asia-india-55050012."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1038\/075486c0","article-title":"The inoculation accident at Mulkowal","volume":"75","author":"Ross","year":"1907","journal-title":"Nature"},{"key":"ref_14","unstructured":"Prince, H.N., Prince, D.L., and Contamination control (2005). The life and Death of Bacteria and Other Germs. Contract Pharma. Microbiol., 1\u20137. Available online: https:\/\/www.nelsonlabs.com\/wp-content\/uploads\/2019\/08\/Contamination-Control-The-life-and-death-of-bacteria-and-other-germs.pdf."},{"key":"ref_15","unstructured":"Centers for Disease Control and Prevention (CDC) (1997). Epidemiologic notes and reports. Nosocomial bacteremias associated with intravenous fluid therapy-USA. 1971. MMWR Morb. Mortal. Wkly. Rep., 46, 1227\u20131233. Available online: https:\/\/pubmed.ncbi.nlm.nih.gov\/9427215\/."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"778","DOI":"10.1128\/am.28.5.778-784.1974","article-title":"In-use contamination of intravenous infusion fluid","volume":"28","author":"Maki","year":"1974","journal-title":"Appl. Microbiol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"486","DOI":"10.1128\/jcm.2.6.486-497.1975","article-title":"Nationwide epidemic of septicemia caused by contaminated intravenous products: Mechanisms of intrinsic contamination","volume":"2","author":"Mackel","year":"1975","journal-title":"J. Clin. Microbiol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"471","DOI":"10.1016\/0002-9343(76)90713-0","article-title":"Nationwide epidemic of septicemia caused by contaminated intravenous products. I. Epidemiologic and clinical features","volume":"60","author":"Maki","year":"1976","journal-title":"Am. J. Med."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1017\/dmp.2015.137","article-title":"Clinical Response, outbreak investigation, and epidemiology of the fungal meningitis epidemic in the United States: Systematic review","volume":"10","author":"Abbas","year":"2016","journal-title":"Disaster Med. Public Health Prep."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"881","DOI":"10.1016\/j.ajpath.2013.05.007","article-title":"Exserohilum infections associated with contaminated steroid injections: A clinicopathologic review of 40 cases","volume":"183","author":"Ritter","year":"2013","journal-title":"Am. J. Pathol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"552","DOI":"10.3201\/eid2303.161334","article-title":"Fungal contamination of methylprednisolone causing recurrent lumbosacral intradural abscess","volume":"23","author":"Renfrow","year":"2017","journal-title":"Emerg. Infect. Dis."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"269","DOI":"10.36076\/ppj.2004\/7\/269","article-title":"Methicillin-resistant Staphylococcus aureus epidural abscess after transforaminal epidural steroid injection","volume":"7","author":"Kabbara","year":"2004","journal-title":"Pain Physician"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"773","DOI":"10.1016\/j.ajic.2008.12.009","article-title":"The prevalence of multidose vial contamination by aerobic bacteria in a major teaching hospital, Shiraz, Iran, 2006","volume":"37","author":"Motamedifar","year":"2009","journal-title":"Am. J. Infect. Control"},{"key":"ref_24","first-page":"890","article-title":"Catheter-related bloodstream infections in patients receiving central parenteral nutrition: Prevalence, associated factors, and treatment","volume":"37","year":"2020","journal-title":"Nutr. Hosp."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"72","DOI":"10.1177\/17411343211033887","article-title":"A review and analysis of product recall for pharmaceutical drug product","volume":"18","author":"Miglani","year":"2022","journal-title":"J. Generic Med."},{"key":"ref_26","unstructured":"(2025, February 24). European Medicines Agency Defective Product Report. Available online: https:\/\/www.ema.europa.eu\/en\/search?search_api_fulltext=quality%20defects."},{"key":"ref_27","first-page":"383","article-title":"Microbial diversity in pharmaceutical product recalls and environments","volume":"61","author":"Jimenez","year":"2007","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_28","first-page":"42","article-title":"Review of Reported Recalls Involving Microbiological Control 2004\u20132011 with Emphasis on FDA Considerations of \u2018Objectionable Organisms","volume":"15","author":"Sutton","year":"2012","journal-title":"Am. Pharm. Rev."},{"key":"ref_29","first-page":"48","article-title":"Analysis of FDA Enforcement Reports (2012\u20132019) to Determine the Microbial Diversity in Contaminated Non-Sterile and Sterile Drugs","volume":"21","author":"Jimenez","year":"2019","journal-title":"Am. Pharm. Rev."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"103993","DOI":"10.1016\/j.drudis.2024.103993","article-title":"A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023","volume":"29","author":"Patel","year":"2024","journal-title":"Drug Discov. Today"},{"key":"ref_31","unstructured":"Tidswell, E., and Azab, W. (2025, February 24). The Cost of Microbial Control. Available online: https:\/\/www.pda.org\/pda-letter-portal\/home\/full-article\/the-cost-of-microbial-control."},{"key":"ref_32","unstructured":"European Pharmacopoeia (2023). Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.4."},{"key":"ref_33","unstructured":"United States Pharmacopeia (2023). Microbiological examination of non-sterile products: Acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 1111."},{"key":"ref_34","unstructured":"European Pharmacopoeia (2023). Sterility. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.1."},{"key":"ref_35","unstructured":"United States Pharmacopeia (2023). Sterility tests. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 71."},{"key":"ref_36","unstructured":"Japanese Pharmacopoeia (2021). Sterility test, JP XVIII."},{"key":"ref_37","unstructured":"Japanese Pharmacopoeia (2021). Microbial attributes of non-sterile pharmaceutical products. JP XVIII, The Ministry of Health, Labour And Welfare."},{"key":"ref_38","unstructured":"European Pharmacopoeia (2023). Microbiological examination of non-sterile products: Microbial enumeration tests. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.12."},{"key":"ref_39","unstructured":"United States Pharmacopeia (2023). Microbiological examination of nonsterile products microbial enumeration tests. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 61."},{"key":"ref_40","unstructured":"European Pharmacopoeia (2023). Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.8."},{"key":"ref_41","unstructured":"European Pharmacopoeia (2023). Microbiological examination of non-sterile products: Test for specified micro-organisms. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.13."},{"key":"ref_42","unstructured":"United States Pharmacopeia (2023). Microbiological examination of nonsterile products tests for specified microorganisms. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 62."},{"key":"ref_43","unstructured":"United States Pharmacopeia (2023). Microbiological examination of nonsterile products tests for Burkholderia cepacia complex. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 60."},{"key":"ref_44","unstructured":"European Pharmacopoeia (2023). Live Biotherapeutic Products. Ph. Eur., 11, 3053."},{"key":"ref_45","unstructured":"European Pharmacopoeia (2023). Microbiological examination of live biotherapeutic products: Tests for enumeration of microbial contaminants. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.36."},{"key":"ref_46","unstructured":"European Pharmacopoeia (2023). Microbiological examination of live biotherapeutic products: Tests for specified micro-organisms. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.38."},{"key":"ref_47","unstructured":"European Pharmacopoeia (2023). Microbiological examination of cell-based preparations. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.27."},{"key":"ref_48","unstructured":"European Pharmacopoeia (2023). Viral safety. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.7."},{"key":"ref_49","unstructured":"European Pharmacopoeia (2023). Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.1."},{"key":"ref_50","unstructured":"European Pharmacopoeia (2023). Pyrogens. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.8."},{"key":"ref_51","unstructured":"United States Pharmacopeia (2023). Pyrogen Test. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 151."},{"key":"ref_52","unstructured":"Japanese Pharmacopoeia (2021). Pyrogen Test, JP XVIII."},{"key":"ref_53","doi-asserted-by":"crossref","unstructured":"Franco, E., Garcia-Recio, V., Jim\u00e9nez, P., Garrosa, M., Girb\u00e9s, T., Cordoba-Diaz, M., and Cordoba-Diaz, D. (2018). Endotoxins from a Pharmacopoeial Point of View. Toxins, 10.","DOI":"10.3390\/toxins10080331"},{"key":"ref_54","first-page":"337","article-title":"A description of cellular coacgulation in the limulus","volume":"115","author":"Levin","year":"1964","journal-title":"Bull. Johns. Hopkins Hosp."},{"key":"ref_55","first-page":"265","article-title":"The Role of endotoxin in the extracellular coagulation of limulus blood","volume":"115","author":"Levin","year":"1964","journal-title":"Bull. Johns. Hopkins Hosp."},{"key":"ref_56","doi-asserted-by":"crossref","unstructured":"Tamura, H., Reich, J., and Nagaoka, I. (2021). Outstanding Contributions of LAL Technology to Pharmaceutical and Medical Science: Review of Methods, Progress, Challenges, and Future Perspectives in Early Detection and Management of Bacterial Infections and Invasive Fungal Diseases. Biomedicines, 11.","DOI":"10.3390\/biomedicines9050536"},{"key":"ref_57","unstructured":"European Pharmacopoeia (2023). Bacterial Endotoxins. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.14."},{"key":"ref_58","unstructured":"United States Pharmacopeia (2023). Bacterial Endotoxins Test. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 85."},{"key":"ref_59","unstructured":"Japanese Pharmacopoeia (2021). Bacterial Endotoxins Test, JP XVIII."},{"key":"ref_60","unstructured":"European Pharmacopoeia (2023). Monocyte Activation Test. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.30."},{"key":"ref_61","unstructured":"European Pharmacopoeia (2023). Test for Bacterial Endotoxins Using Recombinant Factor C. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.32."},{"key":"ref_62","unstructured":"United States Pharmacopeia (2023). Use of Recombinant Reagents in the Bacterial Endotoxins Test. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 1085.1."},{"key":"ref_63","unstructured":"European Pharmacopoeia (2023). Depyrogenation of Items Used in the Production of Parenteral Preparations. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.12."},{"key":"ref_64","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s40268-013-0005-9","article-title":"Potential risks of pharmacy compounding","volume":"13","author":"Gudeman","year":"2013","journal-title":"Drugs RD"},{"key":"ref_65","unstructured":"United States Pharmacopeia (2023). Pharmaceutical Compounding\u2014Sterile Preparations. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 797."},{"key":"ref_66","unstructured":"European Pharmacopoeia (2023). Microbiological examination of human tissues. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.39."},{"key":"ref_67","first-page":"65","article-title":"Infections connected with organ and tissue transplantation","volume":"63","author":"Laudy","year":"2024","journal-title":"Adv. Microbiol."},{"key":"ref_68","unstructured":"European Commission (2025, February 24). Good Manufacturing Practice (GMP) Guidelines, EudraLex\u2014Volume 4, Brussels. Available online: https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en."},{"key":"ref_69","unstructured":"(2025, February 24). The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Available online: https:\/\/health.ec.europa.eu\/document\/download\/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf."},{"key":"ref_70","first-page":"63","article-title":"Microbiological environmental monitoring in pharmaceutical facility","volume":"3","author":"Ashour","year":"2011","journal-title":"Egypt. Acad. J. Biolog. Sci. G Microbiol."},{"key":"ref_71","unstructured":"Cundell, T. (2016). Mold Monitoring and control in pharmaceutical manufacturing areas. Am. Pharm. Rev., 19, Available online: https:\/\/www.americanpharmaceuticalreview.com\/Featured-Articles\/190686-Mold-Monitoring-and-Control-in-Pharmaceutical-Manufacturing-Areas\/."},{"key":"ref_72","unstructured":"United States Pharmacopeia (2023). Microbiological control and monitoring of aseptic processing environments. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 1116."},{"key":"ref_73","unstructured":"Rubenfire, A. (2025, February 24). Baxter to Pay $18.2 Million in Settlement Over Mold at Manufacturing Facility. Available online: https:\/\/www.modernhealthcare.com\/article\/20170112\/NEWS\/170119945\/baxter-to-pay-18-2-million-in-settlement-over-mold-at-manufacturing-facility."},{"key":"ref_74","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1007\/s00228-019-02631-2","article-title":"A systematic review and meta-analysis of microbial contamination of parenteral medication prepared in a clinical versus pharmacy environment","volume":"75","author":"Frijlink","year":"2019","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_75","doi-asserted-by":"crossref","first-page":"392","DOI":"10.5731\/pdajpst.2011.00765","article-title":"A review of cleanroom microflora: Types, trends, and patterns","volume":"65","author":"Sandle","year":"2011","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_76","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1080\/15459620701389909","article-title":"Mold contamination and air handling units","volume":"4","author":"Wilson","year":"2007","journal-title":"J. Occup. Environ. Hyg."},{"key":"ref_77","doi-asserted-by":"crossref","first-page":"434","DOI":"10.5731\/pdajpst.2021.012636","article-title":"Microbial contamination in water systems","volume":"76","author":"Sandle","year":"2022","journal-title":"PDA J. Pharm. Sci. Technol."},{"key":"ref_78","unstructured":"(2025, February 24). Guidance on Quality of Water for Pharmaceutical Use. Available online: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-quality-water-pharmaceutical-use_en.pdf."},{"key":"ref_79","unstructured":"European Pharmacopoeia (2023). Water purified. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 0008."},{"key":"ref_80","unstructured":"European Pharmacopoeia (2023). Water for injections. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 0169."},{"key":"ref_81","unstructured":"European Pharmacopoeia (2023). Water for preparation of extracts. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2249."},{"key":"ref_82","first-page":"7","article-title":"Microbiological analysis of water used for pharmaceutical product preparation","volume":"15","author":"Khaleque","year":"2020","journal-title":"IOSR J. Pharm. Biol. Sci."},{"key":"ref_83","first-page":"2034","article-title":"Review of the media selection and incubation conditions for the compendial sterility and microbial limit tests","volume":"Volume 28","author":"Cundell","year":"2002","journal-title":"Pharmacopeial Forum"},{"key":"ref_84","first-page":"6","article-title":"Evaluation of microbial recovery from raw materials for pharmaceutical use","volume":"4","author":"Eissa","year":"2016","journal-title":"J. Food Pharm. Sci."},{"key":"ref_85","doi-asserted-by":"crossref","first-page":"1147","DOI":"10.1126\/science.124.3232.1147","article-title":"Contamination of human cell cultures by pleuropneumonialike organisms","volume":"124","author":"Robinson","year":"1956","journal-title":"Science"},{"key":"ref_86","unstructured":"European Pharmacopoeia (2023). Mycoplasmas. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.6.7."},{"key":"ref_87","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1016\/j.biologicals.2010.03.002","article-title":"The scope of mycoplasma contamination within the biopharmaceutical industry","volume":"38","author":"Armstrong","year":"2010","journal-title":"Biologicals"},{"key":"ref_88","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1023\/A:1022913015916","article-title":"Mycoplasma contamination of cell cultures: Incidence, sources, effects, detection, elimination, prevention","volume":"39","author":"Drexler","year":"2002","journal-title":"Cytotechnology"},{"key":"ref_89","doi-asserted-by":"crossref","first-page":"2588","DOI":"10.1002\/bit.27362","article-title":"Current technologies to endotoxin detection and removal for biopharmaceutical purification","volume":"117","author":"Schneier","year":"2020","journal-title":"Biotechnol. Bioeng."},{"key":"ref_90","doi-asserted-by":"crossref","first-page":"1425","DOI":"10.2217\/fmb-2020-0153","article-title":"Endotoxin contamination of single-use sterile surgical gloves","volume":"15","author":"Takahashi","year":"2020","journal-title":"Future Microbiol."},{"key":"ref_91","first-page":"385","article-title":"Microbiological control in the manufacture of sterile pharmaceutical products","volume":"46","year":"1971","journal-title":"Pharm. Acta Helv."},{"key":"ref_92","doi-asserted-by":"crossref","first-page":"1308","DOI":"10.1136\/bjo.2007.115618","article-title":"Bacterial contamination of ophthalmic solutions used in an extended care facility","volume":"91","author":"Jokl","year":"2007","journal-title":"Br. J. Ophthalmol."},{"key":"ref_93","first-page":"81","article-title":"Bacterial contamination of multi-dose eye drops at ophthalmology department, University of Gondar, Northwest Ethiopia. Middle East","volume":"24","author":"Tsegaw","year":"2017","journal-title":"Afr. J. Ophthalmol."},{"key":"ref_94","doi-asserted-by":"crossref","first-page":"1518","DOI":"10.1136\/bjo.2008.144469","article-title":"Microbial contamination of multiply used preservative-free artificial tears packed in reclosable containers","volume":"92","author":"Kim","year":"2008","journal-title":"Br. J. Ophthalmol."},{"key":"ref_95","first-page":"151","article-title":"Microbial contamination of preserved ophthalmic drops in outpatient departments: Possibility of an extended period of use","volume":"12","author":"Fazeli","year":"2004","journal-title":"DARU"},{"key":"ref_96","first-page":"1109","article-title":"Exophiala infection from contaminated injectable steroids prepared by a compounding pharmacy\u2014United States, July-November 2002","volume":"51","author":"Engemann","year":"2002","journal-title":"Morb. Mortal. Wkly. Rep."},{"key":"ref_97","doi-asserted-by":"crossref","first-page":"103","DOI":"10.2147\/DHPS.S246050","article-title":"Pharmaceutical quality of selected metronidazole and ciprofloxacin infusions marketed in south eastern Nigeria","volume":"12","author":"Oli","year":"2020","journal-title":"Drug Healthc. Patient Saf."},{"key":"ref_98","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1016\/j.mmcr.2018.01.004","article-title":"Mould meningitis associated with intravenous drug use","volume":"20","author":"Shah","year":"2018","journal-title":"Med. Mycol. Case Rep."},{"key":"ref_99","first-page":"18","article-title":"Catheter associated blood stream infections in patients receiving parenteral nutrition: A prospective study of 850 patients","volume":"5","author":"Hanly","year":"2013","journal-title":"J. Clin. Med. Res."},{"key":"ref_100","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1097\/01.mcg.0000212606.13348.f7","article-title":"Epidemiology of blood-stream infections in patients receiving long-term total parenteral nutrition","volume":"41","author":"Marra","year":"2007","journal-title":"J. Clin. Gastroenterol."},{"key":"ref_101","unstructured":"European Pharmacopoeia (2023). Methods of Preparation of Sterile Products. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.1."},{"key":"ref_102","doi-asserted-by":"crossref","unstructured":"Daehn, T., Schneider, A., Knobloch, J., Hellwinkel, O.J.C., Spitzer, M.S., and Kromer, R. (2021). Contamination of multi dose eyedrops in the intra and perioperative context. Sci. Rep., 11.","DOI":"10.1038\/s41598-021-99892-8"},{"key":"ref_103","doi-asserted-by":"crossref","first-page":"3147","DOI":"10.2147\/OPTH.S320987","article-title":"Microbial contamination of extended use ophthalmic drops in ophthalmology clinic","volume":"15","author":"Chua","year":"2021","journal-title":"Clin. Ophthalmol."},{"key":"ref_104","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1038\/eye.2009.129","article-title":"The precautionary principle: What is the risk of reusing disposable drops in routine ophthalmology consultations and what are the costs of reducing this risk to zero?","volume":"24","author":"Somner","year":"2010","journal-title":"Eye"},{"key":"ref_105","doi-asserted-by":"crossref","first-page":"1691","DOI":"10.1007\/s00417-023-05977-7","article-title":"Bacterial contamination of multi-use antibiotic steroid eye ointments and drops","volume":"261","author":"Yilmaz","year":"2023","journal-title":"Graefe\u2019s Arch. Clin. Exp. Ophthalmol."},{"key":"ref_106","doi-asserted-by":"crossref","unstructured":"Lee, J.H., Kang, M.J., Sim, H.E., and Hwang, J.H. (2022). Microbial contamination of preservative-free artificial tears based on instillationtechniques. Pathogens, 11.","DOI":"10.3390\/pathogens11050592"},{"key":"ref_107","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1167\/tvst.9.7.7","article-title":"Microbial cross-contamination in multidose eyedrops: The impact of instillation angle and bottle geometry","volume":"9","author":"Yu","year":"2020","journal-title":"Transl. Vis. Sci. Technol."},{"key":"ref_108","doi-asserted-by":"crossref","first-page":"449","DOI":"10.5935\/0004-2749.20210070","article-title":"Evaluation of microbial contamination in multi-dose fluorescein eyedrops in a reference eye center","volume":"84","author":"Costa","year":"2021","journal-title":"Arq. Bras. Oftalmol."},{"key":"ref_109","doi-asserted-by":"crossref","first-page":"30","DOI":"10.1111\/cxo.12821","article-title":"Microbial contamination of multiple-use bottles of fluorescein ophthalmic solution","volume":"102","author":"Kyei","year":"2019","journal-title":"Clin. Exp. Optom."},{"key":"ref_110","doi-asserted-by":"crossref","first-page":"2639","DOI":"10.1001\/archinte.165.22.2639","article-title":"Outbreak of catheter-associated Klebsiella oxytoca and Enterobacter cloacae bloodstream infections in an oncology chemotherapy center","volume":"165","author":"Watson","year":"2005","journal-title":"Arch. Intern. Med."},{"key":"ref_111","doi-asserted-by":"crossref","first-page":"1705","DOI":"10.1001\/archinternmed.2009.290","article-title":"Multistate outbreak of Serratia marcescens bloodstream infections caused by contamination of prefilled heparin and isotonic sodium chloride solution syringes","volume":"169","author":"Blossom","year":"2009","journal-title":"Arch. Intern. Med."},{"key":"ref_112","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1086\/597383","article-title":"Epidemiologic investigation of a 2007 outbreak of Serratia marcescens bloodstream infection in Texas caused by contamination of syringes prefilled with heparin and saline","volume":"30","author":"Su","year":"2009","journal-title":"Infect. Control Hosp. Epidemiol."},{"key":"ref_113","doi-asserted-by":"crossref","unstructured":"Centers for Disease Control and Prevention (CDC) (2012). Multistate outbreak of fungal infection associated with injection of methylprednisolone acetate solution from a single compounding pharmacy\u2014United States, 2012. Morb. Mortal. Wkly. Rep., 61, 839\u2013842.","DOI":"10.1016\/j.annemergmed.2012.12.012"},{"key":"ref_114","doi-asserted-by":"crossref","first-page":"135","DOI":"10.2217\/fmb.12.138","article-title":"Exserohilum rostratum fungal meningitis associated with methylprednisolone injections","volume":"8","author":"Casadevall","year":"2013","journal-title":"Future Microbiol."},{"key":"ref_115","doi-asserted-by":"crossref","first-page":"1610","DOI":"10.1056\/NEJMoa1304879","article-title":"Multistate fungal infection clinical investigation team. clinical findings for fungal infections caused by methylprednisolone injections","volume":"369","author":"Chiller","year":"2013","journal-title":"N. Engl. J. Med."},{"key":"ref_116","doi-asserted-by":"crossref","first-page":"173.e5","DOI":"10.1016\/j.ajic.2008.10.007","article-title":"Epidemiology of bloodstream infection associated with parenteral nutrition","volume":"36","author":"Opilla","year":"2008","journal-title":"Am. J. Infect. Control"},{"key":"ref_117","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1177\/0148607105029005367","article-title":"Parenteral nutrition as a risk factor for central venous catheter-related infection","volume":"29","author":"Beghetto","year":"2005","journal-title":"J. Parent. Ent. Nutr."},{"key":"ref_118","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1177\/026119291604400305","article-title":"More than 70 Years of Pyrogen Detection: Current State and Future Perspectives","volume":"44","author":"Fennrich","year":"2016","journal-title":"Altern. Lab. Anim."},{"key":"ref_119","first-page":"169","article-title":"New approaches to the issue of pyrogens in parenteral preparations","volume":"73","year":"2025","journal-title":"Ceska Slov. Farm."},{"key":"ref_120","doi-asserted-by":"crossref","first-page":"365","DOI":"10.1016\/j.scitotenv.2019.05.036","article-title":"Endotoxin contamination, a potentially important inflammation factor in water and wastewater: A Review","volume":"681","author":"Zhang","year":"2019","journal-title":"Sci. Total Environ."},{"key":"ref_121","doi-asserted-by":"crossref","first-page":"1767","DOI":"10.1248\/bpb.b20-00489","article-title":"Endotoxin Contamination and Reaction Interfering Substances in the Plant Extract Library","volume":"43","author":"Kawakami","year":"2020","journal-title":"Biol. Pharm. Bull."},{"key":"ref_122","unstructured":"Centers for Disease Control and Prevention (CDC) (1998). Endotoxin-like reactions associated with intravenous gentamicin\u2014California, 1998. Morb. Mortal. Wkly. Rep., 47, 877\u2013880."},{"key":"ref_123","doi-asserted-by":"crossref","first-page":"1122","DOI":"10.1056\/NEJM199904083401417","article-title":"Gentamicin Contaminated with Endotoxin","volume":"340","author":"Krieger","year":"1999","journal-title":"N. Engl. J. Med."},{"key":"ref_124","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1007\/s40268-023-00412-y","article-title":"A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug- and Medical Device-Borne Endotoxin","volume":"23","author":"Tidswell","year":"2023","journal-title":"Drugs RD"},{"key":"ref_125","doi-asserted-by":"crossref","first-page":"1073","DOI":"10.1007\/s12272-001-1272-8","article-title":"Effects of endotoxin derived from Escherichia coli lipopolysaccharide on the pharmacokinetics of drugs","volume":"31","author":"Yang","year":"2008","journal-title":"Arch. Pharm. Res."},{"key":"ref_126","unstructured":"Centers for Disease Control and Prevention (2004). Notice to readers: Manufacturer\u2019s recall of nasal spray contaminated with Burkholderia cepacia complex. MMWR, 53, 246."},{"key":"ref_127","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1016\/j.ajic.2017.11.018","article-title":"B. cepacia investigation workgroup. A multistate investigation of health care-associated Burkholderia cepacia complex infections related to liquid docusate sodium contamination, January\u2013October 2016","volume":"46","author":"Glowicz","year":"2018","journal-title":"Am. J. Infect. Control"},{"key":"ref_128","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/j.jhin.2004.03.016","article-title":"The microbial content of non-sterile pharmaceuticals distributed in Norway","volume":"57","author":"Charnock","year":"2004","journal-title":"J. Hosp. Infect."},{"key":"ref_129","doi-asserted-by":"crossref","first-page":"2021","DOI":"10.2147\/IDR.S355331","article-title":"Microbiological quality of selected local and imported non-sterile pharmaceutical products in Dar es Salaam, Tanzania","volume":"15","author":"Myemba","year":"2022","journal-title":"Infect. Drug Resist."},{"key":"ref_130","doi-asserted-by":"crossref","unstructured":"Ekeleme, U.G., Ikwuagwu, V.O., Chukwuocha, U.M., Nwakanma, J.C., Adiruo, S.A., Ogini, I.O., and Ude, I.U. (2024). Detection and characterization of micro-organisms linked to unsealed drugs sold in Ihiagwa community, Owerri, Imo State, Nigeria. Access Microbiol., 6.","DOI":"10.1099\/acmi.0.000752.v3"},{"key":"ref_131","doi-asserted-by":"crossref","first-page":"443","DOI":"10.2147\/TCRM.S12253","article-title":"Microbial contamination of nonsterile pharmaceuticals in public hospital settings","volume":"6","author":"Mugoyela","year":"2010","journal-title":"Ther. Clin. Risk Manag."},{"key":"ref_132","unstructured":"United States Pharmacopeia (2023). Application of water activity determination to nonsterile pharmaceutical products. USP 46\u2014NF 41, United States Pharmacopeia. Chapter 1112."},{"key":"ref_133","unstructured":"European Pharmacopoeia (2023). Water-solid interactions; determination of sorption-desorption isotherms and of water activity. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 2.9.39."},{"key":"ref_134","doi-asserted-by":"crossref","first-page":"00064","DOI":"10.15406\/ijvv.2016.03.00064","article-title":"Burkholderia cepacia in pharmaceutical industries","volume":"3","author":"Ali","year":"2016","journal-title":"Int. J. Vaccines Vaccin."},{"key":"ref_135","doi-asserted-by":"crossref","unstructured":"Kumar, S.P., Uthra, K.T., Chitra, V., Damodharan, N., and Pazhani, G.P. (2024). Challenges and mitigation strategies associated with Burkholderia cepacia complex contamination in pharmaceutical manufacturing. Arch. Microbiol., 206.","DOI":"10.1007\/s00203-024-03921-9"},{"key":"ref_136","doi-asserted-by":"crossref","unstructured":"Tavares, M., Kozak, M., Balola, A., and S\u00e1-Correia, I. (2020). Burkholderia cepacia complex bacteria: A feared contamination risk in water-based pharmaceutical products. Clin. Microbiol. Rev., 33.","DOI":"10.1128\/CMR.00139-19"},{"key":"ref_137","unstructured":"(2025, February 24). Contaminated Povidone-Iodine Solution\u2013Texas, Available online: https:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/00001358.htm."},{"key":"ref_138","doi-asserted-by":"crossref","first-page":"295","DOI":"10.1016\/j.jhin.2017.09.012","article-title":"Outbreak of Burkholderia cepacia pseudobacteraemia caused by intrinsically contaminated commercial 0.5% chlorhexidine solution in neonatal intensive care units","volume":"98","author":"Song","year":"2018","journal-title":"J. Hosp. Infect."},{"key":"ref_139","doi-asserted-by":"crossref","first-page":"4217","DOI":"10.1128\/AAC.00138-07","article-title":"Outbreaks associated with contaminated antiseptics and disinfectants","volume":"51","year":"2007","journal-title":"Antimicrob. Agents Chemother."},{"key":"ref_140","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1016\/j.ajic.2019.06.011","article-title":"Investigation of an outbreak of Burkholderia cepacia infection caused by drug contamination in a tertiary hospital in China","volume":"48","author":"Zou","year":"2020","journal-title":"Am. J. Infect. Control"},{"key":"ref_141","doi-asserted-by":"crossref","first-page":"543","DOI":"10.1016\/j.bjid.2015.06.009","article-title":"Polyclonal outbreak of bacteremia caused by Burkholderia cepacia complex and the presumptive role of ultrasound gel","volume":"19","author":"Nannini","year":"2015","journal-title":"Braz. J. Infect. Dis."},{"key":"ref_142","doi-asserted-by":"crossref","first-page":"263","DOI":"10.4103\/ijmm.IJMM_19_249","article-title":"Ultrasound gel as a source of hospital outbreaks: Indian experience and literature review","volume":"37","author":"Solaimalai","year":"2019","journal-title":"Indian J. Med. Microbiol."},{"key":"ref_143","unstructured":"(2025, February 24). FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections, Available online: https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-updates-multistate-outbreak-burkholderia-cepacia-infections."},{"key":"ref_144","doi-asserted-by":"crossref","first-page":"535","DOI":"10.5731\/pdajpst.2011.00793","article-title":"Burkholderia cepacia: This decision is overdue","volume":"65","author":"Torbeck","year":"2011","journal-title":"PDA J. Pharm. Sci. Tech."},{"key":"ref_145","unstructured":"(2025, February 24). FDA Advises Drug Manufacturers that Burkholderia cepacia Complex Poses a Contamination Risk in Non-Sterile, Water-Based Drug Products, Available online: https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile?source=govdelivery&utm_medium=email&utm_source=govdelivery."},{"key":"ref_146","doi-asserted-by":"crossref","unstructured":"Duong, H., Minogue, E., Fullbrook, S., Barry, T., and Reddington, K. (2024). A culture-independent nucleic acid diagnostics method for use in the detection and quantification of Burkholderia cepacia complex contamination in aqueous finished pharmaceutical products. PLoS ONE, 16.","DOI":"10.1371\/journal.pone.0303773"},{"key":"ref_147","first-page":"68","article-title":"Fungal contamination of pharmaceutical products: The growing menace","volume":"19","author":"Sandle","year":"2014","journal-title":"Eur. Pharm. Rev."},{"key":"ref_148","doi-asserted-by":"crossref","first-page":"2834","DOI":"10.1128\/JCM.00908-09","article-title":"Outbreak of intestinal infection due to Rhizopus microsporus","volume":"47","author":"Cheng","year":"2009","journal-title":"J. Clin. Microbiol."},{"key":"ref_149","doi-asserted-by":"crossref","first-page":"7062016","DOI":"10.1155\/2019\/7062016","article-title":"Qualitative and quantitative microbiological studies of paediatric artemether-lumefantrine dry powders and paracetamol syrups obtained from selected drug stores in Accra, Ghana","volume":"2019","author":"Opoku","year":"2019","journal-title":"J. Trop. Med."},{"key":"ref_150","doi-asserted-by":"crossref","first-page":"1","DOI":"10.18231\/2348-0335.2018.0001","article-title":"Effect of primary packaging on microbiological status of oral solid dosage form","volume":"6","author":"Khana","year":"2018","journal-title":"J. Appl. Pharm. Res."},{"key":"ref_151","first-page":"70","article-title":"Contamination of herbal medicinal products marketed in Kaduna metropolis with selected pathogenic bacteria","volume":"25","author":"Abba","year":"2008","journal-title":"Afr. J. Tradit. Complement. Altern. Med."},{"key":"ref_152","first-page":"1618","article-title":"Assessment of the microbial quality of some oral liquid herbal medicines marketed in Ile-Ife, South-Western Nigeria","volume":"10","author":"Igbeneghu","year":"2016","journal-title":"AJMR"},{"key":"ref_153","first-page":"18","article-title":"Microbial contamination of herbal medicines in Africa 2000\u20132024: A systematic review","volume":"30","author":"Ahiabor","year":"2024","journal-title":"Environ. Health Insights"},{"key":"ref_154","doi-asserted-by":"crossref","unstructured":"Alharbi, S.F., Althbah, A.I., Mohammed, A.H., Alrasheed, M.A., Ismail, M., Allemailem, K.S., Alnuqaydan, A.M., Baabdullah, A.M., and Alkhalifah, A. (2024). Microbial and heavy metal contamination in herbal medicine: A prospective study in the central region of Saudi Arabia. BMC Complement. Med. Ther., 24.","DOI":"10.1186\/s12906-023-04307-y"},{"key":"ref_155","doi-asserted-by":"crossref","unstructured":"De Sousa Lima, C.M., Fujishima, M.A.T., de Paula Lima, B., Mastroianni, P.C., de Sousa, F.F.O., and da Silva, J.O. (2020). Microbial contamination in herbal medicines: A serious health hazard to elderly consumers. BMC Complement. Med. Ther., 20.","DOI":"10.1186\/s12906-019-2723-1"},{"key":"ref_156","doi-asserted-by":"crossref","unstructured":"Wang, G., Jiao, M., Hu, J., Xun, Y., Chen, L., Qiu, J., Ji, F., Lee, Y.-W., Shi, J., and Xu, J. (2024). Quantitative analysis of fungal contamination of different herbal medicines in China. Toxins, 16.","DOI":"10.3390\/toxins16050229"},{"key":"ref_157","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1055\/s-2002-20060","article-title":"Microbial contamination of medicinal plants\u2014A review","volume":"68","author":"Kneifel","year":"2002","journal-title":"Planta Med."},{"key":"ref_158","doi-asserted-by":"crossref","first-page":"976","DOI":"10.1080\/15569543.2021.1925696","article-title":"Fungal and mycotoxin occurrence, affecting factors, and prevention in herbal medicines: A review","volume":"41","author":"Yu","year":"2021","journal-title":"Toxin Rev."},{"key":"ref_159","first-page":"3397","article-title":"Mould and mycotoxin contamination of medicinal materials","volume":"6","author":"Qin","year":"2011","journal-title":"Zhongguo Zhong Yao Za Zhi"},{"key":"ref_160","doi-asserted-by":"crossref","unstructured":"Chen, L., Guo, W., Zheng, Y., Zhou, J., Liu, T., Chen, W., Liang, D., Zhao, M., Zhu, Y., and Wu, Q. (2020). Occurrence and characterization of fungi and mycotoxins in contaminated medicinal herbs. Toxins, 12.","DOI":"10.3390\/toxins12010030"},{"key":"ref_161","first-page":"253","article-title":"Traditional herbal medicines: Microbial contamination, consumer safety and the need for standards","volume":"102","author":"Govender","year":"2006","journal-title":"South Afr. J. Sci."},{"key":"ref_162","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1186\/s41182-020-00295-8","article-title":"Prevalence and dynamics of clinically significant bacterial contaminants in herbal medicines sold in East Africa from 2000 to 2020: A systematic review and meta-analysis","volume":"49","author":"Walusansa","year":"2021","journal-title":"Trop. Med. Health"},{"key":"ref_163","first-page":"1465","article-title":"Evaluation of the pharmaceutical and microbial safety, as well as the reliability, of some natural pharmaceutical products available in Iraq","volume":"77","year":"2022","journal-title":"Arch. Razi Inst."},{"key":"ref_164","doi-asserted-by":"crossref","first-page":"865","DOI":"10.4103\/jfmpc.jfmpc_315_17","article-title":"Herbal medicines: Saudi population knowledge, attitude, and practice at a glance","volume":"7","author":"Koshm","year":"2018","journal-title":"J. Fam. Med. Prim. Care"},{"key":"ref_165","unstructured":"European Pharmacopoeia (2023). Alternative methods for control of microbiological quality. Ph. Eur., European Directorate for the Quality of Medicines and HealthCare (EDQM) Council of Europe. [11th ed.]. Chapter 5.1.6."},{"key":"ref_166","doi-asserted-by":"crossref","first-page":"e18899","DOI":"10.1590\/s2175-97902020000318899","article-title":"Rapid identification of microbial contaminants in pharmaceutical products using a PCA\/LDA-based FTIR-ATR method","volume":"57","year":"2021","journal-title":"Braz. J. Pharm. Sci."},{"key":"ref_167","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.jpba.2013.01.005","article-title":"Detection of Escherichia coli in drugs with antibody conjugated quantum dots as immunofluorescence probes","volume":"78\u201379","author":"Wu","year":"2013","journal-title":"J. Pharm. Biomed. Anal."},{"key":"ref_168","first-page":"1189","article-title":"Correlation of bacteria in the contaminated drug and the environmental microbes in the clean room for pharmaceutical microbial test investigated by FTIR","volume":"42","author":"Pei","year":"2007","journal-title":"Yao Xue Xue Bao"},{"key":"ref_169","doi-asserted-by":"crossref","first-page":"831","DOI":"10.1086\/507336","article-title":"Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacy","volume":"43","author":"Civen","year":"2006","journal-title":"Clin. Infect. Dis."},{"key":"ref_170","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1093\/cid\/ciu218","article-title":"Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy","volume":"59","author":"Gupta","year":"2014","journal-title":"Clin. Infect. Dis."},{"key":"ref_171","doi-asserted-by":"crossref","first-page":"212","DOI":"10.1542\/peds.2005-2617","article-title":"Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another state","volume":"118","author":"Held","year":"2006","journal-title":"Pediatrics"},{"key":"ref_172","doi-asserted-by":"crossref","first-page":"1372","DOI":"10.1086\/592968","article-title":"Pseudomonas fluorescens investigation team: Multistate outbreak of Pseudomonas fluorescens bloodstream infection after exposure to contaminated heparinized saline flush prepared by a compounding pharmacy","volume":"47","author":"Gershman","year":"2008","journal-title":"Clin. Infect. Dis."},{"key":"ref_173","doi-asserted-by":"crossref","unstructured":"Pullirsch, D., Bellemare, J., Hackl, A., Trottier, Y.L., Mayrhofer, A., Schindl, H., Taillon, C., Gartner, C., Hottowy, B., and Beck, G. (2014). Microbiological contamination in counterfeit and unapproved drugs. BMC Pharmacol. Toxicol., 15.","DOI":"10.1186\/2050-6511-15-34"},{"key":"ref_174","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1016\/j.ejpb.2010.03.001","article-title":"Degradation of parabens by Pseudomonas beteli and Burkholderia latens","volume":"75","author":"Amin","year":"2010","journal-title":"Eur. J. Pharm. Biopharm."},{"key":"ref_175","unstructured":"Pfizer Inc. (2025, February 24). Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX\u00ae (Eletriptan Hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products, Available online: https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/pfizer-inc-issues-voluntary-nationwide-recall-2-lots-relpaxr-eletriptan-hydrobromide-40-mg-tablets."},{"key":"ref_176","unstructured":"AvKARE, LLC. (2025, February 24). Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg\/5 mL Due to Potential Bacillus cereus Contamination, Available online: https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due."}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/7\/946\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T17:57:07Z","timestamp":1760032627000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/7\/946"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,23]]},"references-count":176,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2025,7]]}},"alternative-id":["ph18070946"],"URL":"https:\/\/doi.org\/10.3390\/ph18070946","relation":{},"ISSN":["1424-8247"],"issn-type":[{"value":"1424-8247","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,23]]}}}