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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]
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
The first six characters of the GPI define the therapeutic class code, the next two pairs the drug name, and the last four define route, dosage or strength. For example GPI 58-20-00-60-10-01-05 is for the drug nortriptyline HCl cap 10 mg (an antidepressant) and can be further classified as follows: [1]
Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls. Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia [2] [3]
It is conjugated in the kidney for excretion in the urine, where 75% of the drug is excreted, [117] and about 15% is eliminated in feces. [118]: 430 Desmethylmirtazapine is an active metabolite of mirtazapine which is believed to contribute about 3-10% to the drug's overall effects and has a half-life of about 25 hours. [8]
The Rizo-Lopez recall has also affected numerous other cheese brands. In a statement, Sargento clarified the recall had only impacted "a limited amount" of its food service and ingredients products.