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.
Message: 20
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 07:52:52 -0500 (CDT)
Subject: Urgent Nationwide Egg Recall
Thu, 19 Aug 2010 18:46:00 -0500
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.
Message: 21
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 08:03:44 -0500 (CDT)
Subject: Montalvan's Sales, Inc. Recalls "La Nuestra" Brand Frozen Mamey Because of Potential Health Risk
Montalvan's Sales, Inc. Recalls "La Nuestra" Brand Frozen Mamey Because of Potential Health Risk
Fri, 20 Aug 2010 07:50:00 -0500
As a precautionary measure, Montalvan’s Sales, Inc. of Ontario, CA has voluntarily recalled “La Nuestra” brand frozen mamey pulp due to a potential health risk from Salmonella Typhi. Typhoid fever is a life-threatening illness caused by the bacterium Salmonella Typhi.
Message: 22
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 10:46:51 -0500 (CDT)
Subject: Drug Information Update - Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
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).
Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone.
Entacapone is also available as a single-ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own).
For more information, please visit: Stalevo
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Message: 23
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 14:04:02 -0500 (CDT)
Subject: Hillandale Farms of Iowa Conducts Nationwide Voluntary Recall of Shell Eggs Because of Possible Health Risk
Fri, 20 Aug 2010 13:10:00 -0500
Hillandale Farms of Iowa is voluntarily recalling shell eggs 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.
Message: 24
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 14:16:49 -0500 (CDT)
Subject: Urgent Nationwide Frozen Mamey Fruit Products Recall
Urgent Nationwide Frozen Mamey Fruit Products Recall
Fri, 20 Aug 2010 13:29:00 -0500
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.
Message: 25
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 15:02:59 -0500 (CDT)
Subject: Salmonella in Alfalfa Sprouts
Fri, 20 Aug 2010 14:53:00 -0500
New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Snow White Food Products Inc., located in 621 Bergen Street in Brooklyn, New York, is recalling certain packages of "Alfalfa Sprouts" due to the presence of Salmonella. The recalled "Alfalfa Sprouts" is packaged in a 3.5 ounce plastic clamshell container which is uncoded. It has a UPC code of 0-46421-11236-6. The product was distributed in New York State.
Message: 26
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 16:04:37 -0500 (CDT)
Subject: Austinuts Wholesale, Inc. Announces Voluntary Recall of Pistachio Kernel Products
Austinuts Wholesale, Inc. Announces Voluntary Recall of Pistachio Kernel Products
Fri, 20 Aug 2010 15:15:00 -0500
AustiNuts Wholesale, Inc. is issuing this voluntary recall of pistachio kernel products due to a recall that was issued by it's supplier California Delights, Inc. California Delights, Inc issued a recall for two shipments of pistachio kernels received by AustiNuts Wholesale, Inc. in July 2010 due to the possibility of contamination with Salmonella.
Message: 27
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 17:05:41 -0500 (CDT)
Subject: GloryBee Foods Recalls Whole Raw Pistachio and Whole Raw Pistachio Kernels Because of Possible Health Risk
Fri, 20 Aug 2010 16:07:00 -0500
GloryBee Foods, Inc., of Eugene, Oregon is voluntarily recalling Aunt Patty's brand 5 pound bags of Whole Raw Pistachios and 25 lb. boxes of Specialty Commodities brand Whole Raw Pistachios Kernels, because it has the potential to be contaminated with Salmonella, 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 (which may be bloody), nausea, vomiting and abdominal pain.
Message: 28
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 18:59:58 -0500 (CDT)
Subject: Milton's Baking Voluntarily Recalls 24 oz. Multi-Grain Bread in Three States For Undeclared Milk in Some Loaves
Fri, 20 Aug 2010 17:07:00 -0500
Milton's Baking Company is voluntarily recalling Milton's Multi-Grain Bread which was distributed to locations in Northern and Central California, Arizona and Nevada. The company took the precautionary step because the loaves contain milk, an undeclared allergen, which may pose a potential serious and life-threatening health risk to milk-allergic individuals.
Message: 29
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Sat, 21 Aug 2010 14:31:47 -0500 (CDT)
Subject: Luberski Inc. Initiates Voluntary Recall of Large Fresh Shell Eggs Because of Possible Health Risk
Luberski Inc, Initiates Voluntary Recall of Large Fresh Shell Eggs Because of Possible Health Risk
Sat, 21 Aug 2010 14:00:00 -0500
The following statement was released by officials of Luberski Inc. regarding the voluntary recall of shell eggs supplied from Wright County Egg of Galt, Iowa. Luberski Inc. is voluntarily recalling specific Julian dates of shell eggs produced by Wright County Egg of Galt, Iowa because they have the potential to be contaminated with Salmonella.
Message: 30
From: FDA MedWatch <fda@service.govdelivery.com>
Date: Mon, 16 Aug 2010 15:22:40 -0500 (CDT)
Subject: FDA MedWatch - Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
AUDIENCE: Cardiology and Nephrology
ISSUE: FDA 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. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.
BACKGROUND: The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
RECOMMENDATION: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
Read the MedWatch safety alert, including a link to the FDA Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm
Message: 31
From: FDA MedWatch <fda@service.govdelivery.com>
Date: Fri, 20 Aug 2010 11:43:47 -0500 (CDT)
Subject: Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
Audience: Neurology, Cardiology
Issue: FDA notified healthcare professionals that it 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's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.
Background: Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own). It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.
Recommendations: At this time, FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional. FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete.
Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication with Data Summary and the previous related MedWatch alert from March 2010, at: