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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.
Product recall. A product recall is a request from a manufacturer to return a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can ...
Drug recall. 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 ...
The U.S. Food and Drug Administration (FDA) sent a warning letter to Dollar Tree, Inc. last week after an investigation revealed the company failed to remove a children's snack that contained ...
The U.S. Food and Drug Administration has issued a recall for a brand of mushroom-infused chocolates and sweets after dozens of consumers across the country became sick and some were hospitalized.
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps ... While the FDA says the recall is a correction rather than a product removal, ...
The United States Food and Drug Administration ( FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...