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Important Information on the Medical Device User Fee Rates for FY2012
(October 1, 2011 through September 30, 2012) Greetings Registered Establishment: This letter is to notify you of the fiscal year 2012, (October 1, 2011-September 30, 2012), fee rates and payment procedures for medical device user fees payable to the United States Food and Drug Administration, (US FDA). The Federal Food, Drug, and Cosmetic Act, (FDC…
Safe Use Initiative: Acetaminophen Toxicity
Acetaminophen is one of the most commonly used medicines in the United States. When used according to the label directions, it has a well-established record of safety and efficacy. Although acetaminophen overdose is very rare in the context of its broad usage, overdose can be toxic and lead to acute liver failure. Liver injury from…
FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines
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Vasopressin Injection USP, Multiple Dose Vials: Recall – Sub
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FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death
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Class I Medical Device Recall: GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits
Recall Class: Class I Date Recall Initiated: 4/29/11 Product: Vital Signs Passive Humidification Device (Hygroscopic Condenser Humidifier, or “HCH”). This product is manufactured by Vital Signs Devices, a GE Healthcare company. A list of affected product codes and lot numbers is provided on the company’s press release, available on FDA’s website. The affected products were…
Class I Medical Device Recall: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter
Recall Class: Class I Date Recall Initiated: June 28, 2011 Product: Arrow NextStep Antegrade Chronic Hemodialysis Catheter The affected products were manufactured between April 14, 2011 and May 9, 2011: These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. Use: The Arrow NextStep Antegrade Catheter is…
Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects
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Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall
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