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Dunagin Pharmaceuticals Inc. dba Massco Dental, a drug manufacturer in Rogers, Arkansas, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of oral pharmaceutical products including toothpaste and mouth rinse containing sodium fluoride, stannous fluoride, and potassium nitrate. The FDA's August-September 2022 inspection found that the company manufactured these drug products using the same equipment and facilities used to produce nonpharmaceutical materials, creating unacceptable contamination and cross-contamination risks in violation of 21 CFR 211.42(c), which requires separate or defined manufacturing areas. The firm's failure to maintain adequate controls and segregation between pharmaceutical and non-pharmaceutical production rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.