The company, through independent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Use of these products may pose a 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.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse reactions or quality problems experienced with the use of these products 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, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
    Fax: 1-800-FDA-0178

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

Source: FDA

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Name of Product: SolarBlend™ Roof Tiles

Units: About 300 installations

Importer: Suntech America Inc., of San Francisco, Calif.

Manufacturer: Wuxi Suntech Power Co. Ltd., of Wuxi, China

Hazard: The connectors between the solar roof tiles can become loose, posing a fire hazard.

Incidents/Injuries: Suntech has received one report of one fire involving six SolarBlend roof tiles. Only the tiles were damaged and no one was injured.

Description: SolarBlend roof tiles replace conventional roof tiles to provide solar energy to the building. This recall involves all SolarBlend roof tiles with model numbers STP050D-5/ZCB (brown), STP050D-5/ZCF (terra cotta), and STP050D-5/ZCG (gray).

Sold by: Roofing retailers and installers in Arizona, California, Colorado, Florida, Kansas and Nevada from October 2009 through March 2011. Depending on the solar energy system size, installation cost can range from $15,000 to $100,000.

Manufactured in: China

Remedy: Suntech has been notifying consumers directly. Consumers who have not been contacted by Suntech should turn off their solar energy systems immediately. Consumers should contact Suntech to schedule a free inspection and repair of the solar energy system. Suntech will repair the solar energy system at no cost to the consumer.

Consumer Contact: For additional information and to schedule a free inspection and repair of the solar energy systems, contact Suntech toll-free at (888) 770-7122 between 5 a.m. and 4 p.m. PT Monday through Friday or visit the firm’s website at http://www.suntech-power.com/product-safety

Source: CPSC

Recall Insider for Recalls

Name of Product: Gas Powered Backpack Blower

Units: About 16,000

Manufacturer: ECHO Inc., of Lake Zurich, Ill.

Hazard: The fuel line between the fuel tank and carburetor could have been damaged during assembly leading to fuel leakage, posing a fire hazard.

Incidents/Injuries: None reported

Description: This recall involves two models of the ECHO 2-cycle gas powered backpack blowers. The 25.4 cc blowers are orange and black in color and “ECHO” is printed on the pull starter housing and blower tube. Model numbers are on a label near the pull starter handle. Serial numbers are on a label near the gas filler cap. Models and corresponding serial numbers included in this recall:

PB-265L    P093121 35519 through P093121 50152

PB-265L    P078110 20732 through P078110 22309

Sold at: Home Depot and authorized ECHO dealers from August 2011 through January 2012 for about $270.

Manufactured in: United States

Remedy: Consumers should immediately stop using the backpack blowers and return them to an authorized ECHO servicing dealer for a free repair.

Consumer Contact: For additional information, contact ECHO toll-free at (800) 432-3246 between 8:30 a.m. and 4:30 p.m. CT Monday through Friday, or visit the firm’s website at www.echo-usa.com

Source: CPSC

Recall Insider for Recalls

Name of Product: Kelty Single and Double Jogging Strollers

Units: About 3,000

Importer: Kelty, of Boulder, Colo., a division of American Recreation Products

Hazard: The front wheel can come loose during use and cause the stroller to tip over, posing a fall and injury hazard to children in the stroller and adults pushing the stroller.

Incidents/Injuries: There have been three reported incidents with these recalled strollers, including cuts, scrapes and fractured bones to adults, and minor cuts and scrapes to children.

Description: This recall involves Kelty Speedster Swivel Deluxe single jogging strollers and Swivel Deuce double jogging strollers. The strollers have an aluminum frame and a cloth seat with a canopy. They were sold in color combinations blue/gray and orange/gray. “Kelty Kids” is embroidered on the front of the stroller in the child’s leg area. The following model numbers are included in this recall. The model number and stroller name are printed on a tag inside the stroller’s seat area.

Sold at: Juvenile product stores and sporting goods stores nationwide and by Web retailers, including www.kelty.com, from January 2010 through February 2012 for between $375 and $475.

Manufactured in: Philippines

Remedy: Consumers should immediately stop using the recalled strollers and contact Kelty to receive free updated assembly and maintenance instructions.

Consumer Contact: For additional information, contact Kelty toll-free at (866) 349-7225 between 8 a.m. and 4 p.m. MT, or visit the firm’s website at www.kelty.com

Source: CPSC

Recall Insider for Recalls

To date, the Company has received two reports of consumers experiencing cuts to the mouth.

The Goya, Great Value, Hatuey, Mr. Special, Polar, Publix, Regal, and SuperMax brand malta beverage lot codes being recalled are available at http://www.fda.gov/Safety/Recalls/ucm292994.htm

The lot codes are printed directly on the bottles above the label.

The Florida Brewery distributed the 7-oz Goya, Great Value, Hatuey, Mr. Special, Polar, Publix, Regal, and SuperMax brand malta beverages in Florida, Texas, Georgia, California and Puerto Rico during the period December 8, 2011 to February 1, 2012.

About the Recall

The Florida Brewery is working with the U.S. Food and Drug Administration to execute the recall.

The recall only affects the brands and lot codes listed above.

The Florida Brewery learned of this issue from consumer reports and initiated an investigation. The Company’s investigation continues and it is taking steps to ensure that all appropriate measures are taken.

Information for Consumers

Consumers who are in possession of products with lot numbers listed above should return the product to the place of purchase. Consumers will receive either a full refund, product replacement, coupon or product credit.

Consumers can call The Florida Brewery’s consumer hotline at 1-866-872-8860 weekdays between 8am and 8pm eastern standard time, and weekends between 8am and 5pm eastern standard time to obtain additional details on the recall and the product return process.

Source: FDA

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PLEASE NOTE: This recall, initiated on February 22, 2012 to the Retail/Hospital Level, is for Lot # 0693 only. No other lots or sizes of Phenylephrine HCl Injection, USP are subject to this voluntary recall.

American Regent is undertaking this voluntary recall of Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns stemming from the identification of visible particles found in some retained samples of this lot. American Regent has not received any reports of adverse events related to this recall.

Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation.

Phenylephrine HCl Injection, USP is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics, and other healthcare facilities and providers should not use American Regent, Inc., Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot #0693, for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by e-mail, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot # 0693. Those with questions about the return or recall process, please call our Customer Service Department at 1- 800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, emergency rooms, clinics, and other healthcare facilities and providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232: Monday thru Friday from 9:00 AM to 5:00 PM ET.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at pv@luitpold.com by fax to (610) 650-0170, or by phone at 1-800-734-9236: Monday thru Friday from 9:00 AM to 5 PM ET. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS OR FAX OR PHONE.

Source: FDA

Recall Insider for Recalls

Name of Product: Map Pro, Propylene and MAPP Gas Cylinders

Units: 29,026,000 units in the U.S.; 1,371,100 units in Canada

Manufacturer: Worthington Cylinders Wisconsin, LLC, of Chilton, Wis.

Hazard: The seal on the cylinders can leak after torches or other fuel consuming equipment are disconnected from them, posing a fire hazard.

Incidents/Injuries: None reported.

Description: The cylinders contain propylene gas and are used for soldering, brazing, cutting and welding. They contain 14.1 oz Map-Pro, 14.1 oz Propylene or 16 oz MAPP (Methyl Acetylene Propadiene Stabilized). The cylinders are approximately 3” in diameter and 11” tall and are either yellow or black in color. They were sold alone and in kits that include a torch and a cylinder.

The cylinders and torch kits have a variety of labels, including:

Sold at: Various plumbing/HVAC distributors, Home Depot, Lowes and Ace Hardware Stores nationwide and in Canada from October 2004 through January 2012 for about $7 to 13 for cylinders and $45 to 75 for the torch kits.

Manufactured in: United States

Remedy:

Unused cylinders: If the cylinder has never been connected to a torch or other device, do not use cylinder. Return cylinder to store where it was purchased for exchange or full refund.

Partially-used cylinder currently connected to torch or other device: Do not disconnect torch or other device. Take outdoors and ignite the torch and burn off entire contents^* of the cylinder. Disconnect the torch from empty cylinder and dispose of empty cylinder per cylinder label instructions or return it to store where it was purchased for exchange or a full refund.

Partially-used cylinder NOT connected to a torch or other device now: Take cylinder outdoors. Leak test top of the cylinder with soapy water. If bubbles develop, attach the torch. Ignite the torch and burn off entire contents^* of the cylinder. Remove the torch from empty cylinder and dispose of empty cylinder per cylinder label instructions or return it to the store where it was purchased for exchange or a full refund. If no bubbles develop, do not use cylinder. Return it to the store where it was purchased for exchange or a full refund.

^*NEVER LEAVE LIT TORCH AND CYLINDER UNATTENDED. USE TORCH ONLY IN A WELL-VENTILATED AREA.

Consumer Contact: For additional information, contact Worthington Cylinders Wisconsin toll free at (866) 511-8967 between 7 a.m. and 7 p.m. ET Monday through Friday, email the manufacturer at MAPCylinderRecall@worthingtoncylinders.com, or go to www.MAPCylinderRecall.com

Source: CPSC

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Name of Product: Forced Air Heater

Units: About 6,102

Importer/Retailer: Meijer Inc., of Grand Rapids, Mich.

Hazard: Exposed and unshielded electrical components can cause the heater to overheat and melt, posing fire and electrical shock hazards.

Incidents/Injuries: Meijer received one report of a unit’s base burning, melting and damaging the carpet beneath it. No injuries have been reported.

Description: This recall involves Touch Point brand oscillating forced air fan heaters with model number HW-218 and date code 0811. The model number and date code are on a silver sticker on the bottom of the heater. Universal Product Code (UPC) 7-13733-30927-1 is on the bottom of the packaging. The heaters are white, 12 inches tall, 9 inches wide and 8 inches deep. They have two round control knobs and a red warning light on the top front, and a black on/off switch on the front base that controls the fan’s oscillation. The words “Touch Point” appear on the right front of the heater’s base.

Sold exclusively at: Meijer stores in Illinois, Indiana, Kentucky, Michigan and Ohio from September 2011 through November 2011 for about $20.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled heaters and return them to any Meijer store for a full refund.

Consumer Contact: For additional information, contact Meijer at (800) 927-8699 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s website at www.meijer.com

Source: CPSC

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Name of Product: GSM Radio Modules Used in Go!Control Panels

Units: About 40,000

Manufacturer: 2GIG Technologies Inc., of Lehi, Utah

Hazard: GSM radio modules used inside Go!Control Panels for home security systems can overheat and combust, resulting in a fire or burn hazard to consumers.

Incidents/Injuries: The company is aware of 22 reports of the product overheating, including three reports of minor smoke, heat or fire damage to the wall where the control panel was mounted. There have been no reports of injuries.

Description: The GSM radio module in the Go!Control Panel enables wireless communication between the home security system and alarm monitoring companies. The Go!Control panels are 6-inches high and 8.5-inches wide and are made of white plastic. The front of the control panel has a color touch screen display, a speaker and “emergency” and “home” buttons. A home security company name may also appear on the front of the panel. The recalled radio modules are a component used inside the Go!Control panels. A professional home security system installer can identify the recalled module. Consumers cannot identify the module safely.

Sold at: 2GIG sold the GSM radio modules to home security companies and security system equipment distributors nationwide and in Canada between December 2010 and October 2011 for use in Go!Control Panels. Home security companies installed the modules in control panels as part of home security systems that varied greatly in price.

Manufactured in: China

Remedy: 2GIG has directed home security companies to contact consumers, who will receive a free, installed replacement module. If you have not been contacted and have a question about whether your home security system contains the recalled module, contact your home security company or 2GIG. Consumers should not try to disconnect or disable the recalled product.

Consumer Contact: For more information contact your home security company or 2GIG toll-free at (855) 244-4832 from 8 a.m. to 5 p.m. MT Monday through Friday or visit the firm’s website at www.2gig.com

Source: CPSC

Recall Insider for Recalls

Name of Product: Mountain Bicycle Handlebar Stem

Units: 213 in the United States; 83 in Canada

Manufacturer: Post Moderne Corporation, Taiwan

Importer: Shimano American Corporation, Irvine, Calif.

Hazard: The bolts holding the front plate of the stem to the stem body can be pulled out of the threads while the bike is being ridden, causing the rider to lose control of the bike and fall.

Incidents/Injuries: Shimano has received one report of an incident in which the rider fell and received torso and arm injuries.

Description: This recall involves PRO Atherton direct mount bicycle handlebar stems with the model number PRSS0049 and supplied from October 2009 to November 2010. The stem consists of a metal alloy body and front plate and four alloy bolts. The stem body is black with red markings. It has the word “PRO” in four places on the sides and the word “Atherton.” The front plate is black and silver with the PRO logo in the center. The model number is located on the barcode sticker on the backside bottom of the packaging material. Stems with the following identification codes are being recalled: HH, HJ, HK, HL, IA, IC, ID, IE and IF. Some of these stems were outfitted with 18mm bolts instead of 21mm bolts. The identification code is located on the stem body where the handlebars are seated.

Sold at: REI, bicycle specialty stores and dealers nationwide from October 2009 to November 2010 for about $120.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop using bicycles with PRO Atherton handlebar stems and take them to an authorized retailer to determine if the stem on their bike is subject to the recall. Authorized retailers will replace 18mm bolts with 21mm bolts free of charge.

Consumer Contact: For more information and to find an authorized retailer, contact Shimano American Corporation at (800) 353-4719 between 8 a.m. and 5 p.m. PT Monday through Friday, or visit the company’s website at www.shimano.com

Source: CPSC

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