April 18, 2009Drug Shortages: Current Drug Shortages: Morphine Sulfate Oral Solution 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 Guidance for Industry Q10 Pharmaceutical Quality System Source: www.fda.gov Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated) Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated); See Related Information Section Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; MVI Adult Injectable No further supply issues are anticipated Source: www.fda.gov April 17, 2009Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry
Public Workshop on Developing a Consolidated Pediatric Rheumatology Observational Registry; May 12-13, 2009 Source: www.fda.gov Drugs@FDA Downloadable Data Files (updated) Drugs@FDA Downloadable Data Files (updated) Source: www.fda.gov Adverse Event Reporting System (AERS) Statistics (updated) Adverse Event Reporting System (AERS) Statistics (updated) Source: www.fda.gov February First-Time Generic Drug Approvals Office of Generic Drugs: February First-Time Generic Drug Approvals Source: www.fda.gov Guidance for Industry Comprehensive List of Guidance Documents Source: www.fda.gov FDA issues Information for Healthcare Professionals for Insulin Pens FDA issues Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens Source: www.fda.gov Starting June 1 2009, FDA will no longer accept paper submission for Registration and Listing Starting June 1 2009, FDA will no longer accept paper submission for Registration and Listing. For more information, visit the FDA Data Standards Council website Source: www.fda.gov Ceftriaxone (marketed as Rocephin and generics) Ceftriaxone and calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary recommendations noted. Source: www.fda.gov FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc. FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc.
The U.S. Food and Drug Administration (FDA) is warning consumers not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages: Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 No further supply issues are anticipated. See related information section for more information Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension See Web site for additional information Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection See website for additional information Source: www.fda.gov 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 Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) Mallinckrodt continues to work diligently to meet the market need during this temporary period of limited supply. Xanodyne has additional releases starting February 20th, 2009. Vintage Pharmaceuticals will be releasing additional product starting February 11th, 2009. 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: Azactam 1 gram and 2 gram (aztreonam for injection) Current Drug Shortages: Azactam 1 gram and 2 gram (aztreonam for injection), updated related information Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov April 16, 2009Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide
Class I recall due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery. Source: www.fda.gov Recalls and Safety Alerts: Warning on Dietary Supplement ?Venom Hyperdrive 3.0? FDA is warning consumers not to take the dietary supplement "Venom Hyperdrive 3.0," which has been promoted for weight loss. This product has been found to contain sibutramine, a prescription drug used as an appetite suppressant under medical superv... Source: www.accessdata.fda.gov Raptiva (efalizumab) Withdrawal of Raptiva from the U.S. market, due to a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML). Source: www.fda.gov April 15, 2009FDA to Review Medical Devices Marketed Prior to 1976 FDA to Review Medical Devices Marketed Prior to 1976
The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency's most stringent premarket review process. 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 Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Source: www.fda.gov FDA Serves Warrant for Inspection of Westco Fruit and Nuts Inc. At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. 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 Drug Shortages: Current Drug Shortages; Argatroban Injection See Related information section Source: www.fda.gov Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Source: www.fda.gov FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis. Source: www.fda.gov Drug Shortages: Current Drug Shortages; Cisplatin Injection 1mg/ml APP has supplies available and is currently allocating (50 mL vial -NDC 63323-103-51, 100 mL vial -NDC 63323-103-65, and 200 mL - NDC 63323-103-64). Teva has their 50 mL vial (NDC 00703-5747-01) and 100 mL vial (NDC 00703-5748-11) on back order with expected releases in the next several weeks. Bedford has all presentations, including Novaplus presentations, on backorder with no release date. Source: www.fda.gov FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc. FDA Warns Against Consuming Peanuts and Peanut Products Sold by Westco Fruit and Nuts Inc.
The U.S. Food and Drug Administration (FDA) is warning consumers not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination. Source: www.fda.gov Drug Shortages: Current Drug Shortages: Cisplatin Injection 1mg/ml Current Drug Shortages: Cisplatin Injection 1mg/ml, updated related information 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 FDA Uncovers Additional Tainted Weight Loss Products The U.S. Food and Drug Administration is expanding, for the second time, its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. Source: www.fda.gov 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 Serves Warrant for Inspection of Westco Fruit and Nuts Inc. At the request of the U.S. Food and Drug Administration, U.S. Marshals today executed an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. Source: www.fda.gov April 14, 2009Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Related information section for updated Letter from Mallinckrodt 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 List of Authorized Generic Drugs Office of Generic Drugs: List of Authorized Generic Drugs (updated) Source: www.fda.gov Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated) Drug Shortages: Current Drug Shortages: Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg) (updated); See Related Information Section Source: www.fda.gov Recalls and Safety Alerts: Warning on Dietary Supplement ?Venom Hyperdrive 3.0? FDA is warning consumers not to take the dietary supplement "Venom Hyperdrive 3.0," which has been promoted for weight loss. This product has been found to contain sibutramine, a prescription drug used as an appetite suppressant under medical superv... Source: www.accessdata.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: Triamcinolone Hexacetonide (Aristospan) Triamcinolone Hexacetonide (Aristospan); Manufacturing Delays Source: www.fda.gov April 13, 2009April 2009 Patient Safety News April 2009 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Source: www.fda.gov Drug Shortages: Resolved Drug Shortages; Methadone Hydrochloride Injection No further supply issues are anticipated Source: www.fda.gov Drug Shortages: Current Drug Shortages; Leucovorin See web site for additional information Source: www.fda.gov 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 Drug Shortages: Resolved Drug Shortages: Alprostadil 0.5 mg/mL injection See Related Information section Source: www.fda.gov 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 April 12, 2009Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection (updated) Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection (updated)
Drug Shortages: Current Drug Shortages: Leucovorin Calcium Solution for Injection 10 mg/mL, Preservative Free, 50 mL vial, package of 1; 50 mL Novaplus vial, package of 1: Manufacturing Delays Source: www.fda.gov Drug Shortages: Current Drug Shortages: Acyclovir Injection (updated) Drug Shortages: Current Drug Shortages: Acyclovir Injection; see Related Information section for update 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 FDA Approves Drug for an Advanced Form of Kidney Cancer FDA Approves Drug for an Advanced Form of Kidney Cancer
The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. 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 Sprout Recall Due to Potential Contamination with Listeria On April 9, 2009, Amalgamated Produce, Inc. announced that it is voluntarily recalling certain brands of sprouts due to potential contamination with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death. 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 Pistachio Recall Expanded On April 6, 2009, Setton Pistachio, Terra Bella, Calif., expanded its recall of pistachio products. Source: www.fda.gov |
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