Posts Tagged ‘Certain’


FDA Recall Alerts: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients

Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. Food and Drug [...]

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FDA Press Releases: FDA approves Nymalize–first nimodipine oral solution for use in certain brain hemorrhage patients

On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA warns pregnant women to not use certain migraine prevention medicines

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. [...]

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FDA Press Releases: FDA warns consumers not to eat certain ProtiDiet High Protein Chocolate Dream Bars manufactured by Pro-Amino International, Inc., Quebec, Canada

Pro-Amino International Inc., of Saint-Eustache, Quebec, Canada, is recalling the ProtiDiet High Protein Chocolate Dream Bars. The recalled product may contain Salmonella. Food and Drug Administration–Press Releases

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FDA Press Releases: FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers

The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph nodes in patients with breast cancer or melanoma who are undergoing surgery to remove tumor-draining lymph nodes. Food and Drug Administration–Press Releases

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