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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]
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The FDA also encourages users to carry backup supplies for insulin delivery should pump failure persist. Customers with any questions or concerns regarding the recall can reach Tandem Diabetes ...
The recalls came in response to reports of renal failure in pets consuming mostly wet pet foods made with wheat gluten from a single Chinese company, beginning in February 2007. The recall began voluntarily with the Canadian company Menu Foods on March 16, 2007, when a company test showed sickness and death in some of the test animals. Overall ...
The labeling updates, which FDA classified as its most serious Class I recall, gave revised instructions for using the device, such as carefully positioning the pump catheter during operative ...
A feeding tube is a medical device used to provide nutrition to people who cannot obtain nutrition by mouth, are unable to swallow safely, or need nutritional supplementation. The state of being fed by a feeding tube is called gavage, enteral feeding or tube feeding. Placement may be temporary for the treatment of acute conditions or lifelong ...
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. B. Braun Medical did not immediately respond to a Reuters request for comment.