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In the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
Metronidazole, sold under the brand name Flagyl among others, is an antibiotic and antiprotozoal medication. [10] It is used either alone or with other antibiotics to treat pelvic inflammatory disease, endocarditis, and bacterial vaginosis. [10] It is effective for dracunculiasis, giardiasis, trichomoniasis, and amebiasis. [10]
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
1960 – metronidazole, the first nitroimidazole; 1961 – ampicillin; 1961 – spectinomycin; 1961 – sulfamethoxazole; 1961 – trimethoprim, the first dihydrofolate reductase inhibitor; 1962 – oxacillin; 1962 – cloxacillin; 1962 – fusidic acid; 1963 – fusafungine; 1963 – lymecycline; 1964 – gentamicin; 1964 – cefalotin, the ...
Metronidazole: Flagyl: Infections caused by anaerobic bacteria; also amoebiasis, trichomoniasis, giardiasis: Discolored urine, headache, metallic taste, nausea; alcohol is contraindicated: Produces toxic free radicals that disrupt DNA and proteins. This non-specific mechanism is responsible for its activity against a variety of bacteria ...
The warning to healthcare providers followed the company's recall over incompatibility concerns with syringe pumps. (Reporting by Pratik Jain in Bengaluru; Editing by Shilpi Majumdar and Sriraj ...
Secnidazole (trade names Flagentyl, Sindose, Secnil, Solosec) is a nitroimidazole anti-infective.Structurally it actually methyl-metronidazole. Effectiveness in the treatment of dientamoebiasis has been reported. [1]