At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

Today’s action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

The FDA’s chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.

“Today’s seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers,” said Margaret O’K Glavin, associate commissioner of the FDA’s Office of Regulatory Affairs. “FDA will not tolerate a company’s failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so,” she added.

On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA’s findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.

On May 13, 2008, Florida state officials issued a “stop sale” action at SEI’s distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.

ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as “all natural” or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.

Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.

Consumers and health care professionals can report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

For more information, visit:
www.fda.gov/consumer/updates/erectiledysfunction010408.html.

Agricola Zaragoza, Inc. of McAllen, TX is recalling Jalapeno Peppers distributed since June 30th, 2008 because they have 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. 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.

The Jalapeno Peppers were distributed to customers in GA and TX.

The Jalapeno Peppers being recalled were shipped in 35lb. plastic crates and in 50lb. bags with no brand name or label.

The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product.  Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem.

Consumers and retailers who purchased Jalapeno Peppers should contact their supplier to determine if their products are involved in the recall. Commercial manufacturers that have used these recalled Jalapeno Peppers as an ingredient in other products (i.e. salsas, etc.) are encouraged to contact their local FDA office to determine if these products should be recalled.  Additionally, restaurants, retail food stores, and similar retail institutions that have used these Jalapeno Peppers as a garnish or as an ingredient to prepare entrees, salsas or other products are asked to dispose of these products making sure that all such peppers are not inadvertently made available for purchase, salvage or donation and therefore preventing any possibility for human or animal consumption..  Consumers with questions may contact the company at (956)-631-6405.

From Yahoo:

The U.S. government has declared it’s OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing.

Officials reiterated earlier warnings that the people most at risk of salmonella should avoid hot peppers — jalapenos and serranos.

The government still doesn’t know just what caused the salmonella outbreak, and Thursday’s move doesn’t mean tomatoes are cleared. Early on, there was good evidence linking them to the sick, but it’s unlikely that any field where tomatoes were harvested in April and May still is in production.

But among later illnesses, there seems to be more evidence against peppers. The FDA is sending inspectors to Mexico to investigate a packing house that receives peppers from a number of farms.

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Engines used in SpeeCo and Huskee Brand Log Splitters

Units: About 6,400

Manufacturer: American Honda Motor Corp., of Torrance, Calif.

Hazard: The engine’s fuel tank can crack and leak, posing a risk of fire or explosion.

Incidents/Injuries: None reported.

Description: The recall involves Honda engines (model type GCV160LA N1A) used in Split Master by SpeeCo and Huskee brand log splitters. Only engine serial numbers between 5547012 and 6880908 are included in the recall. The serial number is located below the upper shroud near the oil dip-stick. The following models of log splitters are affected by the recall and are either silver/black or red/black colored.

Sold at: The log splitters with the recalled engines were sold at outdoor power equipment dealers and Tractor Supply stores nationwide from January 2007 through June 2008 for between $1,150 and $1,500.

Manufactured in: United States

Remedy: Consumers should immediately stop using the affected log splitters and contact any Honda Lawn and Garden dealer or Honda Engine dealer for a free repair. Registered owners of the recalled log splitters will be mailed a notice.

Consumer Contact: For additional information, contact Honda at (800) 426-7701 between 8:30 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.hondapowerequipment.com

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: TV Stands

Units: About 6,700

Distributor: Studio RTA, of Pico Rivera, Calif.

Manufacturer: King Pao Enterprise Co. Ltd., of Guangdong, China

Hazard: The stability of the stand does not meet industry standards to prevent TV tip-over, posing a risk of injury or death to consumers.

Incidents/Injuries: None reported.

Description: This recall involves “Silhouette” TV stands with black or brushed silver and black frames and three glass shelves. Models included in the recall are 403650 (brushed silver and black) and 404191 (black). Model numbers are printed on the packaging and instruction sheet.

Sold by: Shopko and Boscov’s stores nationwide from September 2007 through June 2008 for about $140.

Manufactured in: China

Remedy: Consumers should immediately remove the TV from stand and contact Studio RTA to receive a free repair kit.

Consumer Contact: For additional information, contact Studio RTA at (888) 309-0299 between 7 a.m. and 5 p.m. PT Monday through Friday. Consumers can also visit the firm’s Web site at www.studiorta.com

Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium).

Roxane Laboratories’ number one priority is for the safety of patients who use our products. A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Roxane Laboratories believes that this may be attributed to yeast contamination in one lot of high-density polyethylene bottles received from a supplier. There are various manifestations of yeast infections. The risk of developing a yeast infection depends on how immunocompromised the patient is. Additionally, there are a range of symptoms in a yeast infection from thrush, skin rash, and blood infections (sepsis). If patients develop an infection they should consult their physician. Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories is voluntarily recalling lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is also being included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots. All other product parameters were within specification and product efficacy is not impacted. There have been no complaints or adverse events reported for the affected lots. This recall is limited to the two lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A or Lot 856693A have been instructed to discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.

Advice For Patients Taking Sodium Polystyrene Sulfonate Suspension USP, 15 g/60 Ml Unit Dose Bottles

If your pharmacist has notified you that you may have received a bottle from one of the lots listed in this recall, please return your Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles to your pharmacist.

If you have NOT been notified by your pharmacist, please check your product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, please contact your pharmacist for further instructions. This recall has been limited to these two specific lots.

Roxane Laboratories is working with the US FDA on this voluntary recall. The products discussed in this press release are available by prescription only, and no injuries have been reported in relation to this issue.

LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , 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. 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.

Thai Basil was distributed through retail stores and direct delivery to customers in Southern California, Arizona , and Nevada on June 30, 2008.

The product was shipped in 14 LB cardboard cartons with 12 individual packages weighting approx.1.2 LB each in clear, unmarked, plastic bags. The exterior cartons were labeled “16 DE SEPTIEMBRE S/N SANTA ROSA TAPACHULA NAYARIT, C.P. 63731″ “Thai Basil” and also had an attached sticker with Airway Bill #027 1947 0861.

No illnesses have been reported to date.

The recall was as the result of a random testing by the FDA which revealed that the finished products contained the Salmonella . The company has suspended distribution and importation of the product as FDA and the company continues their investigation.

Consumers who purchased basil should contact the store where they purchased the product to determine if their basil is the Thai basil involved in the recall. Consumers with questions may contact the company at (714) 554-9293.

Photo: Product Label

Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to 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.

The recalled lot # 01418 of Wild Alaskan Smoked Salmon Nova Lox was distributed in Arizona, California, and Nevada, in Von’s retail outlets and to Delaware, Florida, Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, West Virginia, and Virginia in Food Lion retail outlets.

The product comes in a 3 ounce, blue package marked with lot # 01418 on its rear white label bearing the name of the product, its ingredients, and an expiration date.

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

After routine testing by the Florida Department of Agriculture and Consumer Services, Listeria monocytogenes was found in 3 ounce packages of Wild Alaskan Smoked Salmon Nova Lox.

Consumers who have purchased the recalled 3 ounce packages bearing the lot # 01418 of the salmon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (253) 874-2026 x214.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company’s supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her.  (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).

Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it 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.

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 portions from these lot numbers be returned to the place of purchase for a full refund of purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her that is in stock while additional samples are being tested, they expect to begin shipping again in 2-4 weeks.

Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

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 Rize 2 and Rose 4 Her pills 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.

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Screech and Scream Fountain Fireworks

Units: About 20,000

Distributor: Black Cat Fireworks, of Prairie Village, Kan.

Importer: Shiu Fung Fireworks, of China

Hazard: The firework can produce a loud bang and unexpectedly scatter debris, posing an injury hazard to the user and bystanders.

Incidents/Injuries: No injuries have been reported.

Description: The recalled Screech and Scream Fountain is a firework item with a yellow and red cylinder with red balls. The model name is printed on the front of the tube.

Sold at: Various fireworks stores nationwide from October 2006 through June 2008 for about $7.

Manufactured in: China

Remedy: Consumers should immediately stop using the product and return it to either the place of purchase or Black Cat Fireworks for a full refund.

Consumer Contact: For additional information, call Black Cat Fireworks collect at (913) 649-0537 between 9 a.m. and 5 p.m. CT Monday through Friday, or visit the firm’s Web site at www.blackcatfireworks.com