Recalls of Products Intended for Health, page 4
Product Recalls
Thu, 19 Aug 2010
J & H Besta Expands Nationwide Recall of Slim- 30 Herb Supplement to Include Lot 6032101 Found to Contain an Undeclared Drug Ingredient.
J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement Lot 6032101 distributed by the company was found to contain undeclared Desmethyl Sibutramine, similar in structure to Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Slim-30 Herbal Supplement, therefore the safety and effectiveness of the product is unknown.
http://www.fda.gov/Safety/Recalls/ucm223141.htm
Thu, 19 Aug 2010
COUNTRY Eggs, Inc. Initiates Voluntary Recall of Large AA Loose 15 dozen Fresh Shell Eggs Because of Possible Health Risk
The following statement was released by officials of Country Eggs, Inc. regarding the voluntary
recall of shell eggs supplied from Wright County Egg of Galt, Iowa. Country Eggs, Inc. is voluntary
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. 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…
http://www.fda.gov/Safety/Recalls/ucm223328.htm
Fri, 20 Aug 2010
Hillandale Farms of Iowa Conducts Nationwide Voluntary Recall of Shell Eggs Because of Possible
Health Risk.
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.
http://www.fda.gov/Safety/Recalls/ucm223452.htm
Sat, 21 Aug 2010
Luberski Inc, Initiates Voluntary Recall of Large Fresh Shell Eggs Because of Possible Health Risk.
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.
http://www.fda.gov/Safety/Recalls/ucm223549.htm
Sat, 21 Aug 2010
FDA Proposes Withdrawal of Low Blood Pressure Drug
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.
FDA 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
Sat, 21 Aug 2010
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk.
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.
FDA 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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm223423.htm
Tue, 24 Aug 2010
NuCal Foods Conducts Recall of Shell Eggs Supplied from Hillandale Farms of Iowa Because of Possible Health Risk
RIPON, CALIFORNIA — 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.
http://www.fda.gov/Safety/Recalls/ucm223760.htm
Tue, 24 Aug 2010
Moark, LLC, of Fontana, California, Recalls Shell Eggs Supplied From Hillandale Farms of Iowa Because of Possible Health Risk
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.
http://www.fda.gov/Safety/Recalls/ucm223747.htm
Tue, 24 Aug 2010
Integra Issues URGENT Worldwide Recall of NeuroBalloonTM Catheter
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.
http://www.fda.gov/Safety/Recalls/ucm223824.htm
Tue, 24 Aug 2010
Natural Wellness, Inc. Issues a Nationwide Voluntary Recall of Masxtreme Capsules, Marketed as a Dietary Supplement
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.
Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.
http://www.fda.gov/Safety/Recalls/ucm223937.htm
Wed, 25 Aug 2010
Cardenas Market Brand Label Included in Wright County Egg Recall
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. Eggs included in the recall are labeled with plant number 1026 and Julian dates ranging from 136 to 228. Dates and codes can be found printed on the label. The plant number begins with the letter P and then the number. The Julian date follows the plant number, for example: P-1026 228. There have been confirmed Salmonella enteritidis illnesses relating to the shell eggs and traceback investigations are ongoing.
http://www.fda.gov/Safety/Recalls/ucm224085.htm
Wed, 25 Aug 2010
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
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. The affected eggs were packaged under the Trafficanda Egg Ranch brand names packaged in 12-egg cartons, 20-egg over wrap, and 5 dozen over wrap with the Julian dates ranging from 136 to 229 and plant numbers 1026, 1413, 1720, 1942 and1946. Dates and codes can be found stamped on the end of the egg cartons or the top of the over wrap bag. The plant number begins with the letter P and then the number. The Julian date follows the plant number, for example: P-I946 223.
http://www.fda.gov/Safety/Recalls/ucm224076.htm
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