Regeneca Worldwide, a division of VivaCeuticals, Inc. is conducting a nationwide recall of its entire line of herbal and dietary supplement products pursuant to a Consent Decree entered by the federal court for the Central District of California. This recall applies to all products manufactured and sold between June 1, 2011 and February 8, 2017. These products include, but are not limited to RegeneSlim, RegenErect, RegeneArouse, RegeneBlend, RegeneBoost, RegeneBlast, and RegeneFit. ALL LOT #s ARE INCLUDED IN THIS RECALL. Regeneca products were sold nationwide online using the company’s websites, and through a direct sales force within the United States and Puerto Rico for both consumption and retail sales.
The company has presently ceased doing business in the United States.
Consumers who have purchased Regeneca products subject to this recall are advised to immediately stop using the product and are urged to return it to the place of purchase for a possible exchange. Consumers with questions may contact the
company via email to support@regeneca.com.
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.
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
SILVER SPRING, MD – The SoyNut Butter Co. of Glenview, IL is recalling all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products because they may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. I.M. Healthy Products were distributed in multiple states and may have been purchased in stores or through mail order. They were also distributed to childcare centers and schools in multiple states.
All Best Buy dates of all varieties are affected. I.M. Healthy SoyNut Butter has been packaged in 15 oz plastic jars, individual portion cups, 4 lb plastic tubs, or 45 lb pails. SoyNut Butter is available in Original Creamy, Chunky, Honey Creamy, Unsweetened and Chocolate. The granola has been packaged in individual serving packages, 12 oz bags, 50 oz bags, and 25 lb bulk bag. I.M. Healthy Granola is available in Original, Apple, Blueberry, and Raisin and Cranberry. Best Buy dates can be seen on the labels of the containers stamped in silver or black.
Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney failure and even death.
The recall was initiated after ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill. Nine (100%) of the nine people reached for interview reported either eating I.M. Healthy brand SoyNut Butter at home (five people) in the week before they became ill or attending a childcare center that served I.M. Healthy brand SoyNut Butter.
Consumers who have purchased I.M. Healthy SoyNut Butter products or I.M. Healthy granola products are urged not to consume the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-288-1012, Monday-Friday 9:00-5:00 CST.
A&H Focal Inc. is voluntarily recalling all lots of the following products because many of these products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e. sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making these tainted dietary supplements unapproved drugs.
These undeclared active ingredients poses a threat to consumers because the PDE-5 Inhibitors 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.
Black Ant (4600 mg)
Indian God Lotion
Evil Root (1200 mg)
Germany Black Gold (2800 mg)
Germany Niubian (3000 mg)
Hard Ten Days (4500 mg)
Lang Yi Hao (Chaonogsuopian) (500 mg)
Gold Vigra
Clalis
Ye Lang Shen (5000 mg)
Zhansheng Weige Chaoyue Xilishi (2000 mg)
Zhonghua Niubian (2000 mg)
Stree Overlord (3800 mg)
Max Man (3000 mg)
Hu Hu Sheng Wei
Tiger King
Viagra 100 (2000 mg)
Power V8 Viagra (200 mg)
Dadiyongshi Xiangganglongshengwu
Lien Chan for Seven Days
Maca Gold (6800 mg)
These products were marketed as dietary supplements for male sexual enhancement. All lots of the listed products sold by A&H Focal Inc. since January 2014 to present are included in this recall. The products were mainly sold through Asian Markets located in NJ and NY.
Consumers who have any of the above mentioned products should immediately stop use of the product and properly discard. If you have further distributed this product please notify those individuals of this recall.
Consumers with questions regarding this recall can contact Mr. Henry Choo by calling 646-327-8522, Monday through Saturday, 9am-6pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
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.
Regular Mail or FAX: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addresses form, or submit by fax to 1-800-FDA-0178.
This recall and market action are being conducted with the knowledge of the U.S. Food and Drug Administration.
WASHINGTON May 4, 2016 – The United States Department of Transportation’s National Highway Traffic Safety Administration is expanding and accelerating the recall of Takata air bag inflators. The decision follows the agency’s confirmation of the root cause behind the inflators’ propensity to rupture. Ruptures of the Takata inflators have been tied to ten deaths and more than 100 injuries in the United States.
Under the Amended Consent Order issued to Takata this week, the company is required to make a series of safety defect decisions that will support vehicle manufacturer recall campaigns of an additional estimated 35-40 million inflators, adding to the already 28.8 million inflators previously recalled. These expansions are planned to take place in phases between May 2016 and December 2019. The expansions mean that all Takata ammonium nitrate-based propellant driver and passenger frontal air bag inflators without a chemical drying agent, also known as a desiccant, will be recalled.
“Today’s action is a significant step in the U.S. Department of Transportation’s aggressive oversight of Takata on behalf of drivers and passengers across America,” said Transportation Secretary Anthony Foxx. “The acceleration of this recall is based on scientific evidence and will protect all Americans from air bag inflators that may become unsafe.”
The five recall phases are based on prioritization of risk, determined by the age of the inflators and exposure to high humidity and fluctuating high temperatures that accelerate the degradation of the chemical propellant.
“NHTSA’s aggressive actions in 2015 means this recall is already a year ahead of where it would have been if the agency had waited for this research,” said NHTSA Administrator Mark Rosekind. “As a result, all of the most dangerous inflators responsible for the deaths and injuries are already under recall.”
NHTSA and its independent expert reviewed the findings of three independent investigations into the Takata air bag ruptures and confirmed the findings on the root cause of inflator ruptures. A combination of time, environmental moisture and fluctuating high temperatures contribute to the degradation of the ammonium nitrate propellant in the inflators. Such degradation can cause the propellant to burn too quickly, rupturing the inflator module and sending shrapnel through the air bag and into the vehicle occupants.
“The science clearly shows that these inflators become unsafe over time, faster when exposed to humidity and variations of temperature,” Rosekind added. “This recall schedule ensures the inflators will be recalled and replaced before they become dangerous, giving vehicle owners sufficient time to have them replaced before they pose a danger to vehicle occupants. NHTSA will continue to evaluate all available research and will act quickly to protect safety.”
NHTSA will also consult with affected vehicle manufacturers before revising the Coordinated Remedy Order that governs the accelerated program to obtain and install replacement inflators. The Coordinated Remedy Program will continue to ensure that replacement inflators will be made available to highest-risk vehicles first. The revised Coordinated Remedy Program, to be announced this summer, will detail the updated vehicle prioritization schedule and the schedule by which manufacturers are required to procure sufficient supply of replacement parts to conduct the required recall repairs.
This is the largest and most complex safety recall in U.S. history. Under the Coordinated Remedy Program, NHTSA and manufacturers have committed to seek a 100 percent recall completion rate.
“Everyone plays a role in making sure that this recall is completed quickly and safely, including manufacturers, suppliers and vehicle owners themselves,” Rosekind said. “People who receive notification that there is a remedy available for their vehicle should act immediately to have their inflator fixed. All vehicle owners should regularly check SaferCar.gov for information about any open safety recall on their vehicle and what they can do to have it fixed free of charge.”
The recall expansion does not include inflators that include a chemical desiccant that absorbs moisture. There have been no reported ruptures of the desiccated inflators due to propellant degradation. Under the Amended Consent Order, Takata is required to redirect its research toward the safety of the desiccated inflators. Absent proof that the desiccated inflators are safe, Takata will be required to recall them under the November 2015 Consent Order.
In 2015, NHTSA imposed the largest civil penalty in its history for Takata’s violations of the Motor Vehicle Safety Act, and for the first time used its authority to accelerate recall repairs to millions of affected vehicles. NHTSA also appointed an Independent Monitor to assess, track and report the company’s compliance with the Consent Order and to oversee the Coordinated Remedy Program.
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