Friday, September 28, 2007

Sabanero Inc. Recalls Cheese for Frying and Grating

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Sabanero Inc. Recalls Cheese for Frying and Grating
Contact:
Alfonso Ibañez
305-588-0277
FOR IMMEDIATE RELEASE -- Miami, FL -- September 28, 2007 -- Sabanero Inc. is voluntarily recalling FOR FRYING and GRATING Cheese 5.5 pounds loafs with lot number 177, expiration date of October 22/07 made by COOPERATIVA COLANTA in their San Pedro Plant in Colombia South America. Only products with lot number 177 and expiration date: October 22, 2007 are subject to this recall. Products containing any other dates or references like in 10 oz. or 5.5 Lb. Regular, low Fat or For Frying Cheese are not subject to this recall and should not be returned. This recall was initiated because the Florida Department of Agriculture and Consumer Services revealed a potential for the presence of Staphylococcus aureus.
Please inspect your entire inventory for any of the affected product. If you have any of this recalled date, immediately discontinue use, quarantine the product and return to Sabanero inc. as per the instructions contained in this letter.
This recall is being conducted to the consumer level.
Upon Receipt of this letter, take the following actions:
* This recall extends to the consumer level. Immediately examine your inventory to include this 5.5 Lb. loaf lot

Wednesday, September 26, 2007

Quong Hop & Co. Expands Recall of Tofu

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Quong Hop & Co. Expands Recall of Tofu
Contact:
Quong Hop & Co
650-553-9900
FOR IMMEDIATE RELEASE -- September 19, 2007 -- Quong Hop & Co. of South San Francisco, California is expanding their recall of tofu to include the following products in the following sizes and code dates:
* All varieties and sizes of SOY DELI TOFU coded DEC 17 2007
* 30 OZ SOY DELI ORGANIC NIGARI TOFU coded SEP 23 2007 and OCT 17 2007
* 12 OZ SOY DELI TOFU (water packed) coded SEP 23 and OCT 09 2007
* 16 OZ QUONG HOP TOFU (water packed) coded SEP 23 2007
These products are being recalled 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. Although healthy individuals may suffer only short term symptoms such as high fever, sever headache, stiffness, abdominal pain and diarrhea, Listeria infection in severe cases can cause miscarriages and still births among pregnant women.
The recalled "SOY DELI" and "QUONG HOP" brand products are distributed in the Midwest and West coast through supermarkets and natural food stores.
This expanded recall reflects product produced during the selected period. No additional cases of bacteria have been reported. This is a precaution being taken to help ensure product safety.
The date code can be found on the front panel of all the aforementioned products printed in blue ink.

No illnesses have been reported to date in connection with this problem.
The potential for contamination was noted after a routine test by Washington State Department of Agriculture's Food Safety Program revealed the presence of Listeria monocytogenes in a 12 OZ vacuum pack package of "SOY DELI FIRM ORGANIC NIGARI TOFU". The company is voluntarily recalling all products produced during the same time period as the sampled product to ensure customer safety.
Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 650-553-9900.

MCP Recalls All "Queso Cincho de Guerrero" Produced by "Quesos Sabrosos Mexicanos" Distributed Between April 16 - June 26 Because of Possible Health Risk

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

MCP Recalls All "Queso Cincho de Guerrero" Produced by "Quesos Sabrosos Mexicanos" Distributed Between April 16 - June 26 Because of Possible Health Risk
Contact:
MCP
630-279-8600
FOR IMMEDIATE RELEASE -- September 18, 2007 -- MCP is recalling the "Queso Cincho de Guerrero" produced by "Quesos Sabrosos Mexicanos" because it has the potential to be contaminated with Salmonella, an organism which can cause serious and serious and sometimes 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. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis, and Staphylococcus aureus which can cause nausea, retching, abdominal pain, diarrhea and prostration.
The recall of Queso Cincho de Guerrero produced by "Quesos Sabrosos" was distributed in Indiana, Michigan, Georgia, Texas, and Illinois in retail stores.
The dry hard Mexican cheese comes in wheels of 35

Tuesday, September 25, 2007

Department of Consumer Protection Removes Baby's Bliss Gripe Water From Connecticut Stores Following Voluntary Recall

Recall -- State Press Release

This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Department of Consumer Protection Removes Baby's Bliss Gripe Water From Connecticut Stores Following Voluntary Recall
Contact:
Department of Consumer Protection
860-713-6050
FOR IMMEDIATE RELEASE -- HARTFORD, September 24 -- The Department of Consumer Protection has removed a product from three stores where it was sold, following a voluntary recall by the manufacturer and a U.S. Food and Drug Administration (FDA) warning consumers not to drink or serve the beverage.
The product is Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (shown as "10/08" on the label), distributed by MOM Enterprises, Inc., of San Rafael, Calif. The FDA confirmed through laboratory analysis the presence of cryptosporidium after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.
"We have identified three stores in the state that have sold this beverage, and we have made sure that the product has been removed from sale," Consumer Protection Commissioner Jerry Farrell, Jr. said. "Consumers who have this item at home should be sure it is not coded and dated as described in the FDA warning. If it is, please do not use the beverage, but discard it immediately."
The three stores known to have carried Baby's Bliss Gripe Water are:
* Over the Moon, Avon
* Bissell Pharmacy, Ridgefield
* Starlight Baby, Southbury
All of the above stores have been contacted by Consumer Protection and are aware of the recall.
The most common symptom of infection is watery diarrhea. Other symptoms can include dehydration, weight loss, stomach cramps or pain, fever, nausea and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. While most people with healthy immune systems will recover without treatment, the infection could be serious or life-threatening for certain individuals. Infants, children and pregnant women are susceptible to dehydration resulting from diarrhea, which can be life-threatening. Individuals with weakened immune systems are also at risk for a more serious and life-threatening form of illness.
Parents of children who have recently consumed apple flavored Baby's Bliss Gripe Water and have these symptoms should seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection.
The product was sold in a four-ounce plastic bottle packaged inside of a cardboard carton, labeled with the following: Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor.
MOM Enterprises, Inc. is fully cooperating with FDA's investigation into the cause of the contamination and is recalling all potentially contaminated products. FDA continues to investigate and will provide updates as more information becomes available. Consumers can call the FDA at 1-888-723-3366.

Friday, September 21, 2007

Private Selection=?iso-8859-1?Q?=AE?= Ice Cream Recalled From Ralphs and Fo od 4 Less Stores in California

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

Private Selection® Ice Cream Recalled From Ralphs and Food 4 Less Stores in California
Ice Cream May Contain Egg Not Identified On The Label Classic Churned Light Chocolate Chip Cookie Dough Ice Cream Is Only Flavor Involved
Contact:
Meghan Glynn
(513) 762-1304
FOR IMMEDIATE RELEASE -- Cincinnati, OH -- September 20, 2007 -- Inter-American Products, Inc., a division of The Kroger Co. today announced a recall on all codes of Private Selection Classic Churned Light Chocolate Chip Cookie Dough Ice Cream in 1.75-quart containers.
The ice cream is being recalled because it may contain eggs, which are not listed in the ingredient statement. People who have an allergy to eggs run the risk of serious or life-threatening reaction if they consume this product.
The ice cream was distributed only to Ralphs Food Stores in California and Food 4 Less stores in Southern California. No other Private Selection Ice Cream products are affected by this recall.
Customers are encouraged to return the product to a Ralphs or Food 4 Less store for a full refund.
No illnesses have been reported. For most consumers, there is no safety issue with the ice cream. Consumers with questions or concerns may call Inter-American Products, Inc. at 1-800-697-2448.

TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

TWC Global LLC, Inc. Issues a Voluntary Nationwide Recall of Axcil and Desirin Products Marketed as Dietary Supplements
Contact:
TWC Global, LLC
service@axcil.com
FOR IMMEDIATE RELEASE -- Mountain View, CA -- September 12, 2007 -- TWC Global, LLC, 530 Showers Drive, Suite 7-129, Mountain View, CA 94040, announced today that it is conducting a voluntary nationwide recall of the company's supplement products sold under the names of Axcil and Desirin.
TWC Global is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Axcil and Desirin samples found the products contain potentially harmful, undeclared ingredients. FDA found the lot of 02B07 contains 3 mg/g of sildenafil, the active ingredient of a FDA-approved drug used for ED, as well as sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance.
Both Axcil and Desirin are sold on internet nationwide. The products are sold as a 15-capsule blister pack packaged in a box.
Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portion of the products be returned to TWC Global, LLC immediately for a full purchase price refund. The returning address is: TWC Global, LLC, 530 Showers Drive, Suite 7-129, Mountain View, CA 94040. Please return the unused portion of the product with invoice for refund. Consumers with questions may contact the company at 650-575-0828.
The Company is taking this voluntary action because it is committed and is always concerned with the health of consumers who have taken these products. The Company is reviewing the raw materials used to make these products and the raw material manufacturers and suppliers to identify the source of contamination to ensure that there will be no future issues with regard to Axcil and Desirin's compositions. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers.

Wednesday, September 19, 2007

Quong Hop & Co. Recalls Tofu Because of Possible Health Risk

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market
withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the
product or the company. This listserv covers mainly Class I
(life-threatening) recalls. A complete listing of recalls can be found
in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html





Quong Hop & Co. Recalls Tofu Because of Possible Health Risk


Contact:
Quong Hop & Co
650-553-9900

FOR IMMEDIATE RELEASE -- San Francisco, Calif. -- Sept. 19, 2007 ---
Quong Hop & Co. of South San Francisco, California is recalling all SOY
DELI brand tofu with code date DEC 17 2007 and certain varieties of SOY
DELI and QUONG HOP brand tofu with code date SEP 23 2007.

The recall includes the following products in the following sizes and
code dates:

* All varieties and sizes of SOY DELI TOFU coded DEC 17 2007
* 30 OZ SOY DELI NIGARI TOFU coded SEP 23 2007
* 12 OZ SOY DELI WATER PACK TOFU coded SEP 23 2007
* 16 OZ QUONG HOP WATER PACK TOFU coded SEP 23 2007

These products are being recalled 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. Although healthy
individuals may suffer only short term symptoms such as high fever,
sever headache, stiffness, abdominal pain and diarrhea, Listeria
infection in severe cases can cause miscarriages and still births among
pregnant women. Consumers experiencing any of these symptoms should seek
immediate medical attention.

The recalled "SOY DELI" and "QUONG HOP" brand products are distributed
in the Midwest and West coast throughout supermarkets and natural food
stores.

The date code can be found on the front panel of all the aforementioned
products printed in blue ink.

No illnesses have been reported to date in connection with this problem.


The potential for contamination was noted after a routine test by
Washington State Department of Agriculture's Food Safety Program
revealed the presence of Listeria monocytogenes in a 12 OZ vacuum pack
package of "SOY DELI FIRM ORGANIC NIGARI TOFU". The company is
voluntarily recalling all products produced during the same time period
as the sampled product to ensure customer safety.

Consumers who have purchased the recalled products are urged to return
them to the place of purchase for a full refund. Consumers with
questions may contact the company at 650-553-9900.

Bravo! Issues Nationwide Recall of Select Poultry Products for Dogs and Cats

Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market
withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the
product or the company. This listserv covers mainly Class I
(life-threatening) recalls. A complete listing of recalls can be found
in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html






Bravo! Issues Nationwide Recall of Select Poultry Products for Dogs and
Cats


Contact:
David Bogner
(866) 922-9222

FOR IMMEDIATE RELEASE --Vernon, CT -- Sept. 18, 2007--- Bravo! announces
a voluntary recall of select tubes of three of its poultry products for
cats and dogs. The pet food is being recalled because two of the
products have the potential to be contaminated with Salmonella and
Listeria monocytogenes, while the other product has the potential to be
contaminated with Listeria monocytogenes.

Both Salmonella and Listeria are organisms which can cause serious
infections in dogs and cats, and if there is cross contamination, in
people, especially small children, frail or elderly people, and others
with weakened immune systems. Healthy people with Salmonella infection
may only suffer short-term symptoms, such as high fever, severe
headache, vomiting, nausea, abdominal pain, and diarrhea. Long term
complications can include arthritis and other more serious ailments.
Healthy people with Listeria infection may only suffer short-term
symptoms such as high fever, severe headache, stiffness, nausea,
abdominal pain, and diarrhea. Listeria infection can cause miscarriages
and stillbirths among pregnant women.

The company has received no reports of illness in either people or
animals associated with any of the three products.

The recalled products are distributed nationwide to distributors, retail
stores, internet sales and directly to consumers, and they can be
identified by the batch ID code located on the hang tag attached to the
bottom of the plastic film tubes. The recalled products should not be
sold or fed to pets. Pet owners should return unopened frozen tubes of
food to the store where purchased for a full refund. Pet owners should
dispose of opened tubes of product in a safe manner (example, a securely
covered trash receptacle) and return the washed plastic batch ID tag to
the store where purchased for a full refund.

Recalled Pet Food

Product: Bravo Original Formula Chicken Blend frozen raw food
Product Numbers: 21-102, 21-105, 21-110
Sizes: 2 pound, 5 pound and 10 pound tubes
Batch ID code (on hang tag): 236
Reason for Recall: Salmonella, Listeria

Product: Bravo Original Formula Turkey Blend frozen raw food
Product Numbers: 31-102, 31-105, 31-110
Sizes: 2 pound, 5 pound and 10 pound tubes
Batch ID code (on hang tag): 236
Reason for Recall: Listeria

Product: Bravo Basic Formula Finely Ground Chicken frozen raw food
Product Number: 21-212
Size: 2 pound tube
Batch ID Code (on hang tag): 226
Reason for Recall: Salmonella, Listeria

Other Batch IDs for these same products are not involved in the recall.

Bravo! is issuing this action out of an abundance of caution and
sincerely regrets any inconvenience to pet owners as a result of this
announcement. This voluntary recall has been issued because the FDA
detected the bacteria in samples during a recent review.

In an effort to prevent the transmission of Salmonella from pets to
family members and care givers, the FDA recommends that everyone follow
appropriate pet food handling guidelines when feeding their pets. A
list of safe pet food handling tips can be found at:
http://www.fda.gov/cvm/CVM_Updates/foodbornetips.htm.

People may risk Salmonella infection not only by handling these pet
foods, but also by contact with pets or other surfaces exposed to these
foods, so it is important that they thoroughly wash their hands with hot
water and soap. Anyone who is experiencing the symptoms of Salmonella
or Listeria infection after having handled the recalled product should
seek medical attention. Consumers may report any complaints to FDA's
local District Complaint Coordinator's located on the FDA website:
http://www.fda.gov/opacom/backgrounders/complain.html.

Healthy cats and dogs rarely become sick from Salmonella. Animals ill
with Salmonella will display symptoms similar to the ones listed above
for humans. People who have concerns about whether their pet has
Salmonella or not should contact their veterinarian.

For more information on the Bravo recall, please visit
www.bravorawdiet.com , or call toll free
(866) 922-9222

Tuesday, September 18, 2007

Dole Fresh Vegetables Announces Voluntary Recall of 'Dole Hearts Delight' Packaged Salads

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market
withdrawals from the firms involved as a service to consumers, the
media, and other interested parties. FDA does not endorse either the
product or the company. This listserv covers mainly Class I
(life-threatening) recalls. A complete listing of recalls can be found
in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html
Dole Fresh Vegetables Announces Voluntary Recall of 'Dole Hearts
Delight' Packaged Salads
Contact:
Marty Ordman
1-818-874-4834
FOR IMMEDIATE RELEASE --Monterey, Calif. -- Sept. 17, 2007 --- Dole
Fresh Vegetables, a division of Dole Food Company, Inc., today announced
that it is voluntarily recalling all salad bearing the label "Dole
Hearts Delight" sold in the U.S. and Canada with a "best if used by
(BIUB)" date of September 19, 2007, and a production code of "A24924A"
or "A24924B" stamped on the package. The "best if use by (BIUB)" code
date can be located in the upper right hand corner of the front of the
bag. The salad was sold in plastic bags of 227 grams in Canada and
one-half pound in the U.S., with UPC code 071430-01038.
Symptoms of E. coli O157:H7 exposure could include stomach cramps and
diarrhea. Bloody diarrhea may develop. E. coli disease sometimes leads
to a complication called hemolytic uremic syndrome (HUS). If you
exhibited any of these symptoms within 3 to 5 days of consuming any of
the products specified above, seek medical attention.
To date, Dole has received no reports that anyone has become sick from
eating these products. The recall is occurring because a sample in a
grocery store in Canada was found through random screening to contain E.
coli O157:H7. No other Dole salad products are involved.
Eric Schwartz, President, Dole Fresh Vegetables, stated: "Our
overriding concern is for consumer safety. We are working closely with
the U.S. Food and Drug Administration, the Canadian Food Inspection
Agency, and several U.S. state health departments."
Consumers who may still have any of the "Dole Hearts Delight" salads
with a "best if used by date" of September 19 and a production code of
"A24924A" or "A24924B" should dispose of the product. This product was
sold in Ontario, Quebec and the Maritime Provinces in Canada and in
Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio,
Pennsylvania, Tennessee and neighboring states in the U.S. Consumers
can call the Dole Consumer Center toll-free at 800-356-3111. Consumers
are reminded that products should not be consumed after the "best if
used by" date.
Dole Food Company, Inc., with 2006 revenues of $6.2 billion, is the
world's largest producer and marketer of high-quality fresh fruit, fresh
vegetables and fresh-cut flowers. Dole markets a growing line of
packaged and frozen foods and is a produce industry leader in nutrition
education and research.
This release contains "forward-looking statements," within the meaning
of the Private Securities Litigation Reform Act of 1995 that involve a
number of risks and uncertainties. Forward looking statements, which are
based on management's current expectations, are generally identifiable
by the use of terms such as "may," "will," "expects," "believes,"
"intends" and similar expressions. The potential risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied herein include weather-related phenomena; market
responses to industry volume pressures; product and raw materials
supplies and pricing; changes in interest and currency exchange rates;
economic crises and security risks in developing countries;
international conflict; and quotas, tariffs and other governmental
actions. Further information on the factors that could affect Dole's
financial results is included in its SEC filings, including its Annual
Report on Form 10-K.

Friday, September 14, 2007

B. Braun Medical Inc. Issues Nationwide Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

B. Braun Medical Inc. Issues Nationwide Recall of Normal Saline Flush Syringes with Lot Numbers Ending in "SFR"
Contact:
B. Braun Medical Inc.
(800) 227-2862
FOR IMMEDIATE RELEASE -- September 14, 2007 - B. Braun Medical Inc., Bethlehem, PA, announced on July 30, 2007 a voluntary nationwide recall of Normal Saline Flush syringes with lot numbers ending in "SFR" due to an increase in customer complaints for particulate matter in the saline. The FDA has been apprised of this action.
The introduction of particulate matter into the blood stream may result in phlebitis and / or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause severe injury and / or death. Symptoms would generally be expected to develop quickly and are unlikely to develop more than 24 - 48 hours after the administration of the product. However, the risk associated with use of this product is cumulative and increases with each additional exposure. A patient may not develop any symptoms until they have received multiple doses of the product. To date, B. Braun has received no reports of any patient injury associated with this issue.
Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to usage of this product. Customers that have the affected product in their possession may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
This voluntary recall affects normal saline 3mL in 12mL syringes, designated by product code 513584, and normal saline 10mL in 12mL syringes, designated by product code 513587. Between June 11 and July 18 of this year, B. Braun Medical Inc. distributed approximately 33,000 units of product code 513584 and 1.2 million units of product code 513587 of lot numbers ending in "SFR" to hospitals and distributors. The product code, identified as REF, and lot number, identified as LOT, can be found on the syringe label just below the product description.
These flush syringes have been found to contain particulate matter, which has been identified as a medical grade silicone. While this silicone is biocompatible, routinely used in the medical device industry and is an expected component of these syringes, the visible particulate matter caused by the silicone in these "SFR" lots may pose a health risk.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
* Fax: 1-800-FDA-0178

Tuesday, September 11, 2007

Strong America Limited Issues Alert on Undeclared Sulfites in Great Wall Brand Chinese Wolfberry






Strong America Limited Issues Alert on Undeclared Sulfites in Great Wall
Brand Chinese Wolfberry


Contact:
Mr. Yang
(718) 628-6200

FOR IMMEDIATE RELEASE -- Long Island City, NY -- September 10, 2007 --
Strong America Ltd. of Long Island City, NY is recalling Chinese
Wolfberry, because it may contain undeclared sulfites. People who have a
severe sensitivity to sulfites run the risk of serious or
life-threatening reactions if they consume this product.

The recalled Great Wall brand Chinese Wolfberry is packed in uncoded 7oz
packages and were sold in GA, NY, and TN.

No illnesses have been reported to date.

The recall was initiated after routine sampling by the New York State
Department of Agriculture and Markets Food Inspectors and subsequent
analysis by the Department's Food Laboratory personnel revealed the
presence of sulfites in the product, which were not declared on the
label. The consumption of 10 milligrams of sulfites per serving has been
reported to elicit severe reactions in some asthmatics; Anaphylactic
shock could occur in certain sulfites sensitive individuals upon
ingesting 10 milligrams or more of sulfites. Analysis of the Chinese
Wolfberry revealed that it contained 12.87 milligrams per serving.

Consumers who have Great Wall brand Chinese Wolfberry can return the
product to the place of purchase for a full refund. Consumers with
questions may contact the company at 718-628-6200

Monday, September 10, 2007

Abbott Notifies Users of Precision XtraT, OptiumT, ReliOnR Ultima, Rite AidR and KrogerR Blood Glucose Meters to Check Display Screens






Urgent: Abbott Notifies Users of Precision Xtra(tm), Optium(tm),
ReliOn(r) Ultima, Rite Aid(r) and Kroger(r) Blood Glucose Meters to
Check Display Screens


Contact:
Tama Antonia Donaldson
(510) 749-5449

FOR IMMEDIATE RELEASE -- Alameda, CA -- August 31, 2007 -- Abbott is
initiating a worldwide medical device correction for users of its
Precision Xtra(tm), Optium(tm), ReliOn(r) Ultima, Rite Aid(r) and
Kroger(r) blood glucose meters manufactured after January 31, 2007. If
the meter is dropped on a hard surface, part or all of the display
screen may not work properly or may appear blank, which could result in
an inability to view blood glucose test results. The inability to
generate blood glucose results could result in significant risk for
hypoglycemia or hyperglycemia.

Users of these meters who note that the display screen is not working
properly should immediately stop using their meter as referenced in the
User Guide and call Abbott Diabetes Care customer care for assistance at
1-877-844-4404. Through internal testing, Abbott Diabetes Care has found
that when recently produced meters are dropped onto a hard surface, part
of the display can be jarred or disconnected, thereby making it
difficult to read the lot number or date information, or causing the
screen to appear blank. No injuries have been reported to date.

Patients should keep their glucose meters in the wallet provided to
offer additional protection for the meter. If the meter is dropped on a
hard surface, patients should immediately perform a meter display check.
Instructions on how to do this are detailed in the meter's Users Guide.
If no problems are encountered during the automatic display check, the
meter is ready for use. Customers may call Abbott Diabetes Care customer
care at 1-877-844-4404 to determine the date their meter was
manufactured. Customers may also call customer care if they have
questions or need a replacement meter.

Precision Xtra(tm), Optium, ReliOn(r) Ultima, Rite Aid(r) and Kroger(r)
blood glucose meters have been distributed via retail and mail order
pharmacies, physician offices and distributors. Abbott is notifying
physicians, pharmacists, distributors and registered users by letter.

Blood glucose test strips used with these meters are not affected by
this notification.

More information about this notification is available on the company's
website, www.abbottdiabetescare.com
.

Jensen's Old Fashioned Smokehouse Inc. Recalls Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC brand Smoked Salmon Spread






Jensen's Old Fashioned Smokehouse Inc. Recalls Jensen's Seattle Style
Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC brand Smoked
Salmon Spread Because of Possible Health Risk


Contact:
Mike Jensen
206-669-7590

FOR IMMEDIATE RELEASE -- Seattle, WA -- September 7, 2007 -- Jensen's
Old Fashioned Smokehouse Inc. of Seattle, WA is recalling 480 tubs of
Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion
and 132 tubs of PCC brand Smoked Salmon Spread all-natural, 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. Although healthy individuals may suffer only short-term
symptoms such as high fever, severe headache, stiffness, nausea,
abdominal pain and diarrhea, Listeria infection can cause miscarriages
and stillbirths among pregnant women.

Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion, and PCC
brand Smoked Salmon Spread all - natural were distributed in retail
stores in Western Washington.

Jensen's Seattle Style Wild Smoked Salmon Spread Lemon Dill and Onion is
coded Sell By 10/14/07 and 10/15/07, and PCC brand Smoked Salmon Spread
all-natural is coded Sell By 9/29/07. Both products were sold in 7 oz.
plastic tubs.

No illnesses have been CONFIRMED to date. The recall was the result of a
routine sampling program by the company which revealed that the finished
products contained the bacteria.

Consumers who have purchased Jensen's Seattle Style Wild Smoked Salmon
Spread Lemon Dill and Onion, and PCC brand Smoked Salmon Spread all -
natural are urged to return it to the place of purchase for a full
refund. Consumers with questions may contact the Quality Assurance
Department at Jensen's Smokehouse at 206-364-5569.

Listeria Detected in Organic Pastures Raw Cream






Listeria Detected in Organic Pastures Raw Cream
CDFA Issues Order to Withdraw Product; No Illnesses Reported


Contact:
Steve Lyle
916-654-0462

FOR IMMEDIATE RELEASE -- Sacramento, CA -- September 7, 2007 -- The
California Department of Food and Agriculture has issued an order to
Organic Pastures Dairy Company to withdraw from retail distribution
Grade A raw cream manufactured at their facility in Fresno, due to
detection of Listeria monocytogenes bacteria.

Under the recall, Organic Pastures brand Grade A raw cream with code
dates SEP 14 through SEP 21 is to be pulled immediately from retail
shelves and consumers are strongly urged to dispose of any product
remaining in their refrigerators. Until further notice, Organic Pastures
may not produce raw cream for the retail market.

The quarantine order came following laboratory confirmation of Listeria
monocytogenes bacteria. CDFA inspectors found the bacteria as a result
of product testing conducted as part of routine inspection and sample
collection at the facility.

The withdrawal order involves removal of raw cream from grocery stores,
retail outlets and farmers markets throughout California.

The great majority of cream consumed in California is pasteurized. Raw
cream is not. Pasteurization eliminates the risk of bacterial illness.

Listeria monocytogenes may cause listeriosis among "at risk" people,
including pregnant women, newborns, older adults, and people with
weakened immune systems. Symptoms include fever, muscle aches, and
sometimes nausea or diarrhea. If infection spreads to the nervous
system, symptoms such as headache and stiff neck can occur. Infected
pregnant women may experience only a mild, flu-like illness; however,
infections during pregnancy can lead to more serious problems for the
fetus. Consumers should seek immediate medical care if they develop
these symptoms.

Consumers should discard the raw cream or return it to the place of
purchase for a refund. California consumers who have purchased Organic
Pastures brand raw cream may call the company at 559- 352-6585 with
questions about the product withdrawal.

Friday, September 7, 2007

Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore Tabs, a Product Marketed as a Dietary Supplement






Bodee LLC, Inc. Issues A Voluntary Nationwide Recall of All Zencore
Tabs, a Product Marketed as a Dietary Supplement


Contact:
Bodee LLC
help@zencoretabs.com

FOR IMMEDIATE RELEASE -- Century City, CA - August 31- Bodee LLC, 2222
Avenue of the Stars, 702E, Century City, CA 90067, announced today that
it is conducting a voluntary nationwide recall of all the company's
supplement product sold under the name Zencore Tabs.

Bodee LLC is conducting this recall after being informed by
representatives of the Food and Drug Administration (FDA) that lab
analysis by FDA of Zencore Tabs samples found the product contains
potentially harmful, undeclared ingredients. FDA asserts that its
chemical analysis revealed that one lot of Zencore Tabs contains
aminotadalafil, an analog of tadalafil, the active ingredient of a
FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains
Aminotadalafil is close in structure to tadalafil and is expected to
possess a similar pharmacological and adverse event profile. Further,
FDA declares another lot of Zencore Tabs contains sildenafil, the active
ingredient of another FDA-approved drug used for ED, as well as
sulfosildenafil and sulfohomosildenafil, both are analogs of sildenafil.
All of these undeclared chemicals pose a threat to consumers because
they may interact with nitrates found in some prescription drugs (such
as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart
disease often take nitrates. ED is a common problem in men with these
conditions, and consumers may seek these types of products to enhance
sexual performance.

Zencore Tabs is sold in health food stores and by mail order nationwide
and in Canada. The Zencore Tabs product is sold as a 2-capsule blister
pack packaged in a retail booklet with five booklets in a box.

Customers who have this product in their possession should stop using it
immediately and contact their physician if they have experienced any
problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should
be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or
by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers
Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for
a full purchase price refund by calling (800) 935-0296 for instructions
on the return and refund process.

The Company is taking this voluntary action because it is committed and
is always concerned with the health of persons who have consumed this
product. The Company is reviewing the procedures and policies of all
firms involved with the manufacture of the product to ensure that there
will be no future issues with regard to Zencore Tabs' composition. The
Company is working closely with the FDA in the recall process and is
committed to the quality and integrity of its products. It sincerely
regrets any inconvenience to consumers and its other customers.

Tuesday, September 4, 2007

Consumer Advisory: State Agriculture Director Issues Food Safety Alert for Potato Salad

Consumer Advisory: State Agriculture Director Issues Food Safety Alert
for Potato Salad


Contact:
Communications Office
614-752-9817

FOR IMMEDIATE RELEASE -- August 31, 2007 -- Ohio Department of
Agriculture (ODA) Director Robert Boggs in conjunction with The Kroger
Co. today advises consumers not to consume Kroger brand Mustard or
Southern-Style potato salad with a "Best If Used By" date of Sept. 5,
2007, because it may contain E. coli O157:H7.

ODA's Consumer Analytical Laboratory tested a sample of the Kroger brand
Mustard or Southern-style potato salad collected during routine food
safety sampling, and found it positive for E. coli O157:H7, a foodborne
pathogen.

To date, no illnesses have been reported, and additional samples
analyzed by a certified, thirdparty laboratory contracted by Kroger have
tested negative for E. coli O157:H7. As a precautionary measure, The
Kroger Co. has removed the product from sale. The company encourages
consumers to check their refrigerators and freezers for this specific
product and, if found, to return it to the store for a full refund.

For more information regarding this product withdrawal, please visit
www.kroger.com .

Through ODA's Division of Food Safety, the department helps assure
consumers are provided foods, over-the-counter drugs, dietary
supplements, and cosmetics that are safe, unadulterated, and honestly
presented. Random, routine testing at the department's Consumer
Analytical Laboratory helps identify potentially dangerous or
adulterated products. In addition to advising consumers, the department
has notified the Food and Drug Administration and local health
departments.