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Endo, Inc., the manufacturer of clonazepam, expanded the recall, first announced in July, to 16 lots of the medication, according to a recall notice shared by the FDA on Nov. 19.
Some packages of clonazepam were labeled with the incorrect dosage strength and National Drug Code (NDC), which is the FDA's identifier for drugs, according to Endo, Inc., the drug's manufacturer.
Tablets of the drug clonazepam, the generic name for Klonopin, which is used to treat epilepsy, panic disorder and muscle spasms, have been recalled for incorrect labeling that could inadvertently ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
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 ...
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The Food and Drug Administration (FDA) recalled 79,200 lbs of Kirkland Signature butter - a dairy product made by churning milk or cream - due to an undeclared allergen in October.