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Talk to a SpecialistTalk to a SpecialistGreen Pharmaceuticals Inc. was cited for manufacturing SnoreStop NasoSpray, an OTC homeopathic nasal spray, that violated multiple FDA requirements including adulteration with the bacterium Providencia rettgeri, failure to comply with Current Good Manufacturing Practice (CGMP) standards, and marketing an unapproved new drug. The contamination was particularly significant because the product was labeled for use in children as an anti-snoring nasal spray. FDA testing of lot 2373/21222 revealed gross microbial contamination, and the company's manufacturing records demonstrated inadequate methods, facilities, and controls for processing and holding the drug product.