Contaminated OTC Products: FDA Warns – Diethylene Glycol and Ethylene Glycol
Oct 5, 2023 - Cosmetics
Contaminated OTC Products: FDA Warns – Diethylene Glycol and Ethylene Glycol
An American manufacturer of over-the-counter (OTC) drugs received a warning letter from the US Food and Drug Administration (FDA). The manufacturer's methods, facilities, and controls do not comply with GMP standards, resulting in the manufactured drugs being classified as deficient.
Specifically, it was criticized that not all glycerin batches used were tested according to USP requirements to ensure safety regarding the impurities diethylene glycol (DEG) or ethylene glycol (EG).
In addition, insufficient cleaning and maintenance of production equipment were found. As a result, multiple microbial contaminations were identified in finished products. The FDA is urging the manufacturer to investigate these matters immediately and take appropriate actions to minimize potential risks to consumers.
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Sources:
- https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neilmed-pharmaceuticals-inc-650263-05262023
- https://www.gmp-navigator.com/gmp-news/verunreinigungen-bei-amerikanischem-otc-hersteller?utm_source=Newsletter&utm_medium=email&utm_campaign=NL-QKMIBI-KW38-2023