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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]
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 ...
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.
The FDA has issued a statement following the Class I recall for an IOS app used in conjunction with insulin pumps after 224 injuries were reported.
The FDA has issued a Class I Recall for dog treats sold by Carolina Prime Pet
Approvable letters were issued to applicants at the end of the FDA's review period to indicate that the application or abbreviated application is basically approvable providing certain issues are resolved. It was an indication that the application substantially met FDA requirements if specific conditions, such as labeling changes, are agreed to.
The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale. Smiths ...
An FDA warning letter is an official message ... premarket approval applications for Class III devices to which the Quality System regulation deviations are ...