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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 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, ...
Whether you have cans in your fridge or cases lined up for the holidays, you're going to want to check your sodas.. On November 6, the U.S. Food & Drug Administration issued a recall on Diet Coke ...
The recall is a correction, not a product removal, the FDA said. "This notification is not a device removal and Impella heart pumps remain on the market and available for patients," a J&J ...
The FDA Adverse Event Reporting System ( FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration 's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might ...
The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...