April 11, 2009FDA Alerts the Public to Uncle Chen and Lian How Brand Dry Spice Product Recall FDA Alerts the Public to Uncle Chen and Lian How Brand Dry Spice Product Recall
The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall by Union International Food Company (Union City, Calif.) of the company's dry spice products. The recall is based on an investigation of an ongoing foodborne illness outbreak of Salmonella Rissen. This investigation is being conducted in collaboration with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The company's products are distributed in these states and Arizona. Source: www.fda.gov FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs. Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov FDA Approves Coartem Tablets to Treat Malaria The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds). Source: www.fda.gov FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. Source: www.fda.gov Rulemaking History for Nonprescription Products Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) Source: www.fda.gov Manual of Policies and Procedures Acceptance Criteria for Residual Solvents Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated) Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml (updated)
Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml: See Related Information Section Source: www.fda.gov April 10, 2009On the Road Again: FDA's Mobile Laboratories On the Road Again: FDA's Mobile Laboratories
This article (with slide show) reveals how mobile labs help FDA test food and drugs for contaminants. Source: www.fda.gov Preventing Medical Errors: Confusing Heparin Labels Can Lead to Errors The Institute for Safe Medication Practices (ISMP) points out that some multiple dose heparin vials have potentially confusing labels that could lead to dangerous overdoses. These vials, which contain 4 mL of heparin solution, are labeled "10,000 US... Source: www.accessdata.fda.gov Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) Recall of tablets because they may differ in size and therefore could have more or less of the active ingredient. Source: www.fda.gov February 2009 Safety Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Source: www.fda.gov Preventing Medical Errors: Preventing Overdoses when Using Methadone to Treat Chronic Pain A report from the Institute for Safe Medication Practices lists several reasons for the serious and sometime fatal overdoses that have occurred when methadone is used to treat moderate to severe chronic pain. ISMP points out that methadone differs... Source: www.accessdata.fda.gov April 9, 2009Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection
See Related information section Source: www.fda.gov Preventing Medical Errors: Confusing Heparin Labels Can Lead to Errors The Institute for Safe Medication Practices (ISMP) points out that some multiple dose heparin vials have potentially confusing labels that could lead to dangerous overdoses. These vials, which contain 4 mL of heparin solution, are labeled "10,000 US... Source: www.accessdata.fda.gov Propafenone HCL Tablets Recall due to oversized tablets and risk of serious side effects. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Amikacin sulfate injection Resolved Drug Shortages: Amikacin sulfate injection, No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection) Elan estimates availability of Azactam 1 gram vials (NDC 51479-0041-15), and 2 gram vials (NDC 51479-0042-15)in March/April time frame. For additional information call Elan at 1-800-859-8586, and Baxter has 1 gram (NDC 51479-0048-01) and 2 gram (NDC 51479-0049-01) frozen aztreonam available on allocation. For additional information call Baxter at 1-888-229-0001. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) Follow-up Dear Healthcare Professional Letter added to the Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution, see Related Information section Source: www.fda.gov April 8, 2009Manual of Policies and Procedures (MaPP) Manual of Policies and Procedures (MaPP)
Joint Safety Meetings Between OND and OSE Source: www.fda.gov Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the FDA (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA) Source: www.fda.gov April 7, 2009FDA Approved First DNA Test for Two Types of Human Papillomavirus FDA Approved First DNA Test for Two Types of Human Papillomavirus
The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient's risk of subsequently developing cervical cancer. Source: www.fda.gov FDA Alerts Consumers to Recall of Certain Pistachios The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif. The company has stopped all distribution of processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products. Source: www.fda.gov FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses. Source: www.fda.gov FDA/DIA Statistics Forum 3rd Annual FDA/DIA Statistics Forum: Emerging and Strategic Issues in Drug Development, Personalized Medicine, and a Guidance Update, April 26, 2009, Westin Arlington Gateway, Arlington, VA 22203. Meeting Information Source: www.diahome.org April 6, 2009Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits
Class 1 recall of multiple types of trays and kits due to lack of sterility. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Levoleucovorin (Fusilev) 50 mg single use vials See Web site for additional information Source: www.fda.gov FDA Launches SAFEKIDS Initiative with Academic and Clinical Partners The Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative is a multi-year project designed to address major gaps in scientific information about the safe use of anesthetics and sedatives received by millions of children each year. Source: www.fda.gov FDA Approves New Vaccine to Prevent Japanese Encephalitis The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg) Drug Shortages: Current Drug Shortages: Nitrostat sublingual tablets (0.3 mg, 0.4 mg, and 0.6 mg)
Follow-up Dear Healthcare Professional Letter added to the Related information section Source: www.fda.gov Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection Alprostadil 0.5 mg/mL injection: Teva Pharmaceuticals: Manufacturing delays; Bedford: Manufacturing delays; Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Amikacin sulfate injection Hospira has amikacin available; customer service: 877-946-7747. Teva anticipates their product will be available by the end of February 2009. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov February First-Time Generic Drug Approvals Office of Generic Drugs: February First-Time Generic Drug Approvals Source: www.fda.gov April 5, 2009Division of Drug Marketing, Advertising, and Communications issues 14 letters Division of Drug Marketing, Advertising, and Communications issues 14 letters
Division of Drug Marketing, Advertising, and Communications issues 14 letters Source: www.fda.gov Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Source: www.fda.gov Generic Drug Petition Tracking: Suitability Tracking Reports Generic Drug Petition Tracking: Suitability Tracking Reports Source: www.fda.gov |
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