Search results
Results From The WOW.Com Content Network
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 ...
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
Deprescribing is a process of tapering or stopping medications to achieve improved health outcomes by reducing exposure to medications that are potentially either harmful or no longer required. [1] Deprescribing is important to consider with changing health and care goals over time, as well as polypharmacy and adverse effects. [2]
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 ...
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 ...
a signal word – either Danger or Warning – where necessary; hazard statements, indicating the nature and degree of the risks posed by the product; the identity of the supplier (who might be a manufacturer or importer) Each precautionary statement is designated a code, starting with the letter P and followed by three digits.