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ADERS ® uses NDC barcodes to prevent medication errors

Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our newest barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see....

View a PowerPoint Presentation of ADERS ®. With Sound Approximately 11 Minutes. No Sound at Your Pace.

Share this information with a friend by clicking this link. Preventing medication errors with barcodes.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

Food and Drug Administration--Press Releases

FDA seeks court order against Michigan dairy
Tue, 31 Aug 2010 16:40:00 -0400

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Scenic View Dairy of Hamilton, Mich., its president, and three of its managers alleging that they sold dairy cows for human consumption that contained illegal drug residues in edible tissues.

FDA launches new organizational performance management system
Tue, 31 Aug 2010 13:01:00 -0400

The U.S. Food and Drug Administration today launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government.

FDA Warns Consumers to Avoid TimeOut Capsules
Wed, 25 Aug 2010 14:51:00 -0400

The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.

FDA releases guidance on federal menu labeling requirements
Tue, 24 Aug 2010 14:00:00 -0400

The U.S. Food and Drug Administration today released two documents that outline steps to help chain restaurants comply with new federal nutrition labeling requirements.

FDA Warns of Possible Dangers from Portable Foot-Tanning Device
Tue, 24 Aug 2010 12:50:00 -0400

The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.

Study: Presence of murine leukemia virus found in CFS Patients, others
Mon, 23 Aug 2010 14:32:00 -0400

Researchers have found murine leukemia viruses (MLV) in blood samples collected from patients diagnosed with chronic fatigue syndrome (CFS) and some healthy blood donors, according to a study published online today by the scientific journal Proceedings of the National Academy of Sciences (PNAS).

Urgent Nationwide Egg Recall
Thu, 19 Aug 2010 19:46:00 -0400

The current recall of eggs in their shells, or “shell eggs,” is part of an ongoing and intensive investigation by local, state, and federal officials into the cause of recent cases of Salmonella Enteritidis.

Urgent Nationwide Frozen Mamey Fruit Products Recall
Fri, 20 Aug 2010 14:29:00 -0400

An investigation by the CDC and state partners showed an epidemiologic link between an ongoing outbreak of Salmonella Typhi and frozen mamey fruit products sold under the La Nuestra brand by Montalvan Sales Inc. Ontario, Calif, and under the Goya brand by Goya Foods Inc. Secaucus, New Jersey.

U.S. Marshals seize food from rodent-infested Ga. warehouse
Thu, 19 Aug 2010 14:26:00 -0400

U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized packaged food products from a rodent-infested warehouse in Athens, Ga. A variety of products, including crackers, cookies and potato chips, were intended for sale to jails and prisons throughout the southeastern United States.

FDA Proposes Withdrawal of Low Blood Pressure Drug
Mon, 16 Aug 2010 12:23:00 -0400

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

FDA approves ella™ tablets for prescription emergency contraception
Fri, 13 Aug 2010 17:05:00 -0400

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal
Thu, 12 Aug 2010 11:31:00 -0400

The U.S. Food and Drug Administration today warned that the drug Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.

FDA: Salmonella risk from frozen rodents fed to reptiles
Mon, 09 Aug 2010 15:57:00 -0400

The U.S. Food and Drug Administration is warning U.S. and international customers who may have purchased frozen mice, rats and chicks from Biggers and Callaham LLC, dba/MiceDirect.com, that these products, which are used as food for reptiles, have the potential to be contaminated with Salmonella.

FDA Seeks Injunction Against Colorado Manufacturer of Cultured Cell Product
Fri, 06 Aug 2010 16:53:00 -0400

The U.S. Food and Drug Administration is seeking an injunction in federal court against Regenerative Sciences LLC, of Broomfield, Colo., citing violations of current good manufacturing practice (cGMP) that cause its cultured cell product to be adulterated. The product is also misbranded due to the lack of adequate directions for use and the failure to bear the “Rx only” symbol.

FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Wed, 04 Aug 2010 09:15:00 -0400

The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs on the Reopening of Florida State Waters to Commercial Fishing
Mon, 02 Aug 2010 14:53:00 -0400

We are pleased to be able to support the state of Florida as it reopens state waters off Pensacola to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish that will be coming out of this area.

Statement by Margaret A. Hamburg, Commissioner of Food and Drugs, on the Reopening of Some Mississippi State Waters to Commercial Fishing
Mon, 02 Aug 2010 14:09:00 -0400

We are pleased to be able to support the state of Mississippi as it reopens state waters in the Mississippi Sound, from the mainland to the barrier islands, to commercial fishing. Through close coordination with our state and federal partners, we are confident all appropriate steps have been taken to ensure that seafood harvested from the waters being opened today is safe and that Gulf seafood lovers everywhere can be confident eating and enjoying the fish and shrimp that will be coming out of this area.”

United States Seeks Permanent Injunction Against New York Food Processor
Mon, 02 Aug 2010 08:58:00 -0400

The U.S. Department of Justice, in an action initiated by the U.S. Food and Drug Administration, is seeking a permanent injunction against NY Gourmet Salads, Inc., a processor of ready-to-eat deli salads, seafood salads, and cream cheeses in Brooklyn, N.Y., and Leonard F. Spada, the company's president. (HR)

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
Fri, 30 Jul 2010 16:59:00 -0400

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

FDA Approves Vaccines for the 2010-2011 Influenza Season
Fri, 30 Jul 2010 14:39:00 -0400

The U.S. Food and Drug Administration announced today that it has approved vaccines for the 2010-2011 influenza season in the United States.

Food and Drug Administration--Recalls/Safety Alerts

Whole Foods Market® Announces Recall of Morningland Dairy and Ozark Hills Farm Cheese
Thu, 02 Sep 2010 14:46:00 -0400

The following press release was issued by Whole Foods Market's North Atlantic Region regarding the voluntary recall of Morningland Dairy of Mountain View, Missouri, Raw Goat Milk Mild Cheddar Cheese. Whole Foods Market’s North Atlantic region is announcing a voluntary recall Morningland Dairy and Ozark Hills Farm Raw Goat Milk Mild Cheddar Cheese due to possible contamination by Listeria and Staphylococcus aureus.

Azteca Linda Corp. Expands Recall of Queso Fresco Because of Possible Health Risk
Wed, 01 Sep 2010 18:41:00 -0400

Azteca Linda Corp. of Brooklyn, NY, is expanding the 8/24/10 recall of QUESO FRESCO (FRESH WHITE CHEESE (exp. SEP 11 2010) to include expiration date SEP 12 2010. In addition, the firm is recalling Queso El Azteca brand REQUESON (RICOTTA CHEESE) with expiration date SEP 19 2010 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems...

P&G Voluntarily Recalls a Small Amount of Dry Cat Food
Wed, 01 Sep 2010 14:40:00 -0400

CINCINNATI, August 31, 2010 - The Procter & Gamble Company (P&G) is voluntarily recalling a small number of bags from a specific lot of one of its dry cat food products due to potential salmonella exposure.

QUESERIA CHIPILO INC. Recalls Cheese Products because of Possible Health Risk
Wed, 01 Sep 2010 10:45:00 -0400

August 26, 2010 QUESERIA CHIPILO INC. is announcing a recall of the following cheese products, all date codes up to and including September 26, 2010 – Fresco and Nov 25, 2010 – Oaxaca.

Torn & Glasser Issues Allergy Alert on Undeclared Peanuts Fancy, No Peanuts
Tue, 31 Aug 2010 16:52:00 -0400

Torn & Glasser of Rancho Dominguez, CA is recalling its 3.75lb (#10) cans of “Mixed Nuts Fancy, No Peanuts” marked with lot numbers 0980 and 1940 on the outer case label and bottom lid due to undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled “Mixed Nuts Fancy, No Peanuts” were distributed in CA, WA and HI. This was distributed through a wholesale distribution outlet. The product comes in a sealed, 3.75lb #10 style can marked with lot numbers 0980 and 1940 on the outer case label and bottom lid. The UPC is 072488980761.

Paleta California Co. Announces Voluntary Recall of Frozen Mamey Paletas Because of Potential Contamination with Salmonella Typhi
Tue, 31 Aug 2010 14:42:00 -0400

In response to the voluntary recall by Goya Foods, Inc. of their frozen mamey pulp, Paleta California, Co. is voluntarily recalling its 4 oz. Mamey Supreme Cream Bar (frozen fruit bars also known as “paletas”) due to a potential health risk from Salmonella Typhi. Salmonella Typhi is a bacterium that causes a life-threatening illness called typhoid fever.

Morningland Dairy Conducting Nationwide Voluntary Recall of All Cheese Labeled as Morningland Dairy & Ozark Hills Farm Because of Possible Health Risk
Tue, 31 Aug 2010 14:37:00 -0400

Morningland Dairy of Mountain View, Missouri, is recalling 68,957 pounds of cheese because it may be contaminated with Listeria monocytogene and also has the potential to be contaminated with Staphylococcus aureus.Morningland Dairy’s raw milk cheese is sold in the lower 48 states via mail order, retail stores, crop sharing associations, and direct delivery. The cheese is packaged in vacuum-sealed plastic packages that are sold as random weight size retail packages. The specific varieties of cheese are sold under the following brand names and flavors:

P&G Recalls Small Number of Bags of Cat Food From Stores in Loveland, Colorado
Mon, 30 Aug 2010 11:56:00 -0400

CINCINNATI, August 29, 2010 -- Procter & Gamble (P&G) is voluntarily recalling a small number of bags of its Iams Proactive Health Indoor Weight & Hairball Care dry cat food which may have been sold recently in one or two stores in Loveland, Colorado.

Sparboe Farms Initiated Voluntary Recall Fresh Shell Eggs
Sat, 28 Aug 2010 11:32:00 -0400

Sparboe Farms is voluntarily recalling shell eggs produced by Wright County Egg and Hillandale Farms which were packaged by Sparboe Farms, because they have the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis, or arthritis.

Queseria Chipilo Recalls Cheese Products Because of Possible Health Risk
Fri, 27 Aug 2010 21:50:00 -0400

Queseria Chipilo , Passaic, NJ is announcing to recall of the following cheese products, all date codes up to and including Sept. 26, 2010 Fresco and Nov. 25,2010 Oaxaca.Oaxaca String Cheese Queso Fresco . Queso Fresco. Hoja De Plátano

Fruiti Pops, Inc. Recalls "Fruiti Pops" Brand Mamey Frozen Fruit Bars Because of Potential Health Risk
Fri, 27 Aug 2010 15:52:00 -0400

In response to the voluntary recall of Goya Foods, Inc. frozen mamey pulp, Fruiti Pops, Inc. of Santa Fe Springs, CA is recalling its Fruiti Pops 4 oz. Mamey frozen fruit bars due to a potential health risk from Salmonella typhi. No illnesses have been reported to date in connection with Fruiti Pops Mamey fruit bars.

Cal-Maine Foods, Inc. Clarifies Previous Statement on Nationwide Shell Egg Recall
Fri, 27 Aug 2010 10:41:00 -0400

Cal-Maine Foods, Inc. (NASDAQ: CALM) today issued the following clarification regarding the previously announced voluntary recall of shell eggs supplied from Hillandale Farms of Iowa. This information does not increase the total number of eggs which Cal-Maine purchased from Hillandale Farms, which was previously announced on August 20, 2010. Cal-Maine immediately contacted its customers to ensure that any eggs included in the recall were withdrawn from the marketplace.

Cardenas Market Brand Label Included in Wright County Egg Recall
Wed, 25 Aug 2010 18:03:00 -0400

The following statement was released by officials of Wright County Egg regarding its voluntary recall of some shell eggs in cooperation with the US Food and Drug Administration's (FDA). Wright County Egg of Galt, Iowa is adding one California-distributed brand label – Cardenas Market – to its voluntary recall of August 13, 2010 of specific Julian dates of shell eggs produced by their farms because they have the potential to be contaminated with Salmonella...

Trafficanda Egg Ranch Initiates Voluntary Recall of Medium, Large, X Large, & Jumbo AA Cartons; 5 Dozen Medium Over Wrap & 20 Count Over Wrap, Fresh Shell Eggs Because of Possible Health Risk
Wed, 25 Aug 2010 18:02:00 -0400

The following statement was released by officials of Trafficanda Egg Ranch regarding the voluntary recall of shell eggs supplied from Wright County Egg of Galt, Iowa and distributed by Trafficanda Egg Ranch. Trafficanda Egg Ranch is voluntarily recalling specific Julian dates of Medium, Large, X Large, and Jumbo Cartons; 5 Dozen Medium Over Wrap and 20 Count Over Wrap of shell eggs produced by Wright County Egg of Galt, Iowa because they have the potential to be contaminated with Salmonella...

Azteca Linda Corp. Recalls Queso Fresco and Queso Hebra because of Possible Health Risk
Wed, 25 Aug 2010 09:46:00 -0400

Azteca Linda Corp. of Brooklyn, NY, is recalling QUESO FRESCO (FRESH WHITE CHEESE) and QUESO HEBRA (FRESH WHITE STRING CHEESE) with an expiration date of September 11, 2010 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Natural Wellness, Inc. Issues a Nationwide Voluntary Recall of Masxtreme Capsules, Marketed as a Dietary Supplement - 08/24/10
Tue, 24 Aug 2010 16:59:00 -0400

Natural Wellness is announcing that it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA has determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil...

Integra Issues URGENT Worldwide Recall of NeuroBalloonTM Catheter
Tue, 24 Aug 2010 10:24:00 -0400

Integra LifeSciences Corporation, Plainsboro, New Jersey, has initiated a worldwide recall of the NeuroBalloon Catheter. There were a total of 1,924 units distributed, 258 in the United States of America 1,586 in the European Union and 80 in countries. A total of eight (8) complaints regarding the inflation or deflation of the NeuroBalloon Catheter were received by Integra. All complaints occurred outside the United States. No patient injuries have been reported. As a result of the investigation performed by Integra, it was determined that this condition could exist during pre-implant testing or during the procedure. Integra issued a voluntary recall of the affected lots of the NeuroBalloon Catheter on July 2, 2010.

NuCal Foods Conducts Recall of Shell Eggs Supplied from Hillandale Farms of Iowa Because of Possible Health Risk
Tue, 24 Aug 2010 09:26:00 -0400

RIPON, CALIFORNIA (August 20, 2010) -- The following statement was released by officials of NuCal Foods of Ripon, California regarding the voluntary recall of shell eggs supplied from Hillandale Farms of Iowa. NuCal Foods is voluntarily recalling specific Julian dates of shell eggs produced by Hillandale Farms of Iowa and packaged by NuCal Foods because they have the potential to be contaminated with Salmonella.

Moark, LLC, of Fontana, California, Recalls Shell Eggs Supplied From Hillandale Farms of Iowa Because of Possible Health Risk
Tue, 24 Aug 2010 09:22:00 -0400

Moark, LLC, is voluntarily recalling specific lots of shell eggs produced by Hillandale Farms of Iowa and packaged by Moark, LLC, because they have the potential to be contaminated with Salmonella. Potentially affected eggs that were received by Moark total approximately 24,300 dozen. Moark repackaged the eggs for retail customers (under the brand names Albertsons, Yucaipa Valley, Farmer’s Gems and Mountain Dairy), as well as providing unbranded eggs to foodservice customers. The eggs were sold by Moark to retail and wholesale customers in Southern California and Las Vegas, Nevada.

NY Fish Inc Issues an alert on uneviscerated fish
Mon, 23 Aug 2010 16:42:00 -0400

NY Fish Inc, 738 Chester St, Brooklyn, NY, 11236 is recalling NY Fish Brand (cold) Smoked Herring, with a code of 141, discovered by New York State Department of Agriculture and Markets Food Inspectors during a routine inspection. The product was found to be uneviscerated prior to processing.

What's New: Drugs RSS Feed

Safe Drug Use After a Natural Disaster
Thu, 02 Sep 2010 16:43:00 -0400

Updated

Information Regarding Insulin Storage and Switching Between Products in an Emergency
Thu, 02 Sep 2010 16:34:00 -0400

Updated

New and Generic Drug Approvals
Thu, 02 Sep 2010 14:35:00 -0400

Drug Approval Listing

Newly Added Guidance Documents
Thu, 02 Sep 2010 09:04:00 -0400

Drugs@FDA Data Files
Wed, 01 Sep 2010 13:25:00 -0400

Data files updated through September 1, 2010.

National Drug Code Directory
Wed, 01 Sep 2010 12:56:00 -0400

The National Drug Code has been updated with data through September 1, 2010.

FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections
Wed, 01 Sep 2010 10:00:00 -0400

[09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections.

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
Fri, 27 Aug 2010 14:04:00 -0400

One new report (April to June 2010) and seven updated reports

September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Fri, 27 Aug 2010 09:54:00 -0400

Advisory Committees (Drugs)

Warning Letters 2010
Wed, 25 Aug 2010 13:42:00 -0400

Letters added

FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
Mon, 23 Aug 2010 10:43:00 -0400

[08-20-2010] The U.S. Food and Drug Administration (FDA) is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet).

FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)
Fri, 20 Aug 2010 13:03:00 -0400

[07-13-2010] The U.S. Food and Drug Administration (FDA) is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) – a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced.

FDA Drug Safety Communication: Aseptic meningitis associated with use of Lamictal (lamotrigine)
Mon, 16 Aug 2010 15:17:00 -0400

[08-12-2010] The U.S. Food and Drug Administration (FDA) is informing the public that Lamictal (lamotrigine)†, a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis.

Additions/Deletions for Prescription and OTC Drug Product Lists
Fri, 13 Aug 2010 12:05:00 -0400

The list has been updated through May 2010.

Orange Book Zip File
Fri, 13 Aug 2010 12:00:00 -0400

July 2010 Orange Book data files, zip format.

FDA Drug Safety Communication: Ongoing safety review of Evamist (estradiol transdermal spray) and unintended exposure of children and pets to topical estrogen
Wed, 11 Aug 2010 10:45:00 -0400

[07-29-2010] The U.S. Food and Drug Administration (FDA) is reviewing reports of adverse effects from Evamist in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

FDA Drug Info Rounds
Mon, 09 Aug 2010 07:07:00 -0400

A new series of training videos for practicing clinical and community pharmacists

What's New: Drugs RSS Feed

Safe Drug Use After a Natural Disaster
Thu, 02 Sep 2010 16:43:00 -0400

Updated

Information Regarding Insulin Storage and Switching Between Products in an Emergency
Thu, 02 Sep 2010 16:34:00 -0400

Updated

New and Generic Drug Approvals
Thu, 02 Sep 2010 14:35:00 -0400

Drug Approval Listing

Newly Added Guidance Documents
Thu, 02 Sep 2010 09:04:00 -0400

Drugs@FDA Data Files
Wed, 01 Sep 2010 13:25:00 -0400

Data files updated through September 1, 2010.

National Drug Code Directory
Wed, 01 Sep 2010 12:56:00 -0400

The National Drug Code has been updated with data through September 1, 2010.

September 20, 2010: Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement
Fri, 27 Aug 2010 09:54:00 -0400

Advisory Committees (Drugs)

Warning Letters 2010
Wed, 25 Aug 2010 13:42:00 -0400

Letters added

Additions/Deletions for Prescription and OTC Drug Product Lists
Fri, 13 Aug 2010 12:05:00 -0400

The list has been updated through May 2010.

Orange Book Zip File
Fri, 13 Aug 2010 12:00:00 -0400

July 2010 Orange Book data files, zip format.

FDA Drug Info Rounds
Mon, 09 Aug 2010 07:07:00 -0400

A new series of training videos for practicing clinical and community pharmacists

What's New: Vaccines, Blood & Biologics RSS Feed

August 26, 2010 Approval Letter - Infanrix
Thu, 02 Sep 2010 14:39:00 -0400

a prefilled syringe which has a tip cap which may contain natural rubber latex and plunger which does not contain latex

Infanrix
Thu, 02 Sep 2010 13:04:00 -0400

Jobs at the Center for Biologics Evaluation and Research (CBER)
Thu, 02 Sep 2010 11:58:00 -0400

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

August 23, 2010 Approval Letter - Havrix
Wed, 01 Sep 2010 10:43:00 -0400

Revised the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.

Havrix
Tue, 31 Aug 2010 15:31:00 -0400

Package Insert Updated December 2009 to include additional adverse events.

August 23, 2010 Approval Letter - Engerix-B
Tue, 31 Aug 2010 13:41:00 -0400

to revise the Package Insert and pre-filled syringe carton to include the appropriate warnings regarding latex containing components.

Engerix-B
Tue, 31 Aug 2010 09:12:00 -0400

Biologic Product Shortages
Mon, 30 Aug 2010 14:40:00 -0400

August 24, 2010 Approval Letter - Fluvirin
Thu, 26 Aug 2010 10:16:00 -0400

Influenza Virus Vaccine, Fluvirin®, to revise the Package Insert to include the appropriate warnings regarding natural rubber latex containing components in the tip caps of the pre-filled syringes.

Fluarix
Wed, 25 Aug 2010 10:33:00 -0400

For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.

URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation
Tue, 24 Aug 2010 15:49:00 -0400

URGENT - Voluntary Market Withdrawal of Octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation

July 19, 2010 Approval Letter - Fluarix
Tue, 17 Aug 2010 15:19:00 -0400

Clarification to your approval letter of October 19, 2009, regarding the pediatric study.

Complete List of Currently Approved Premarket Approvals (PMAs)
Thu, 12 Aug 2010 14:22:00 -0400

Information updated through July 31, 2010

Complete List of Currently Approved NDA and ANDA Application Submissions
Thu, 12 Aug 2010 14:20:00 -0400

Information updated through July 31, 2010

Complete List of Substantially Equivalent 510(k) Device Applications
Thu, 12 Aug 2010 14:17:00 -0400

Information updated through July 31, 2010

Recall of Panoscreen lll
Tue, 10 Aug 2010 09:55:00 -0400

Recall of Panoscreen lll

Here are some headlines supporting the benefits of a system like ADERS:

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