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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 3 Mar 2008 05:28:41 -0600 (CST)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 3, 2008 |
The following new items were added to the CDRH web pages on February 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Circulatory System Devices Panel Advisory Meeting, November 29-30, 2007 - Transcripts |  |
| Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Agenda, Roster, Briefing | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 3 Mar 2008 10:05:13 -0600 (CST)
Subject: Gorton's Seafood Recalls 6 Crispy Battered Fish Fillets Due to Possible Adulteration (Feb. 29)
Gorton's Seafood Recalls 6 Crispy Battered Fish Fillets Due to Possible Adulteration (Feb. 29)
Mon, 3 Mar 2008 08:25:00 -0600
Gorton's Seafood, based in Gloucester, Mass., is voluntarily recalling one frozen seafood product with a specific date code because the product may have been adulterated with pills. While there has been only one isolated case of adulteration and no reports of illness from the product, the company is taking this action as a precautionary measure.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 3 Mar 2008 15:38:43 -0600 (CST)
Subject: FDA MedWatch - The March 2008 Patient Safety News Is Now Available
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FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
First Drug to Treat PKU Approved
Kuvan (sapropterin dihydrochloride) increases the activity of phenylalanine hydroxylase in those PKU patients who have some residual functioning of this enzyme…
Recall of Heparin and Saline Flush Syringes
Some Sierra Pre-filled, Inc. and B. Braun syringes could be contaminated with the bacteria Serratia marcescens…
Severe Pain with Osteoporosis Drugs
Incapacitating musculoskeletal pain can occur in patients taking certain bisphosphonate drugs such as Fosamax, Actonel, Reclast and Boniva…
Warning on Exjade and Liver Failure
Patients’ liver function should be monitored monthly due to reported cases of hepatic failure…
Dangerous Skin Reactions from Carbamazepine
These reactions are significantly more common in patients of Asian ancestry…
Potentially Fatal Hyponatremia from Desmopressin
Patients or their caregivers should watch for circumstances that could lead to excessive fluid intake…
Alaris (Medley) Infusion Pumps Recalled
Pump occluder springs may have been misassembled, which can lead to overinfusion and result in serious injury or death…
Preventing Burns from Electric Dental Handpieces
Third degree burns can occur when poorly maintained electric dental handpieces are used…
MedWatch: Reporting Adverse Events
FDA's MedWatch program relies on health care professionals and consumers to report to serious problems with the medical products they prescribe, dispense, or use…
For more
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