Defective Products

December 29, 2010

Oxygen Therapy and Inositol Making False Claims

It is buyer beware when any product label says, “Intended to prevent, treat or cure diseases”. It is particularly buyer beware for the website called www.oxygentherapyprogram.com and its products called Oxygen Therapy (35% Food Grade Hydrogen Peroxide) and Inositol.

Recently, the Food and Drug Administration completed an investigation of 35% Food Grade Hydrogen Peroxide and Inositol and noted several FDA violations. In Fact, the Food and Drug Administration documented that there may be more deficiencies associated with the two products.

First, since the products are intended to diagnose, cure, mitigate, treat, or prevent disease, they fall under the category of classified drugs defined in the Federal Food, Drug, and Cosmetic Act. As such, these products must be recognized as safe and effective for their labeled uses. However, these drugs were not approved by the FDA for safety and efficacy. In addition, new drugs that fall under the classification of the Food, Drug, and Cosmetic Act are not permitted to be introduced to the public until they have been approved. Both 35% Food Grade Hydrogen Peroxide and Inositol have been sold to the public without FDA approval. The FDA also discovered that the product label did not provide adequate directions for a person to use the product without the advice of a physician. This is a misbranding violation.

December 24, 2010

OsteoSymbionics, LLC. Receives FDA Warning about Cranial Implants

by Burton A. Padove

The Food and Drug Administration conducted an investigation of a OsteoSymbionics plant located in Cleveland, Ohio to learn that the company was manufacturing cranial implants which was not in accordance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found in Title 21, Code of Federal Regulations (C.F.R.), Part 820.

The Food and Drug Administration determined that these cranial implants are devices which fall under the Federal Food, Drug and Cosmetic Act because the product is intended for the use of disease diagnosis, mitigation, treatment, disease prevention or may affect the structure or function of the body.

Furthermore, the Food and Drug Administration found that the company had inadequate design controls for the development of the cranial implants, did not establish or maintain procedures for ensuring that specific design requirements are met consistently, and did not establish procedures for validation which limited follow up inspections and testing; including an inadequate sterilization process. The company also failed to maintain a device master record for the cranial plate implants and did not adhere to other regulations.

December 17, 2010

Duro Extend Capsules Recall: Another Dietary Supplement Down!

by Burton A. Padove

The dietary supplement known as Duro Extend Capsules, manufactured by Intelli Health Products, has been recalled throughout the nation. Intelli Health Products took this step after the Food and Drug Administration produced results from an analysis of the product showing that it contains Sulfoaidenafil. Sulfoaidenafil is an ingredient that is FDA approved for the treatment of erectile dysfunction. The reason why Sulfoaidenafil must be FDA approved is because the drug can negatively interact with other prescription drugs when taken together, such as with nitroglycerin. In addition, Duro Extend Capsules may lower your blood pressure to a high risk level. These two noted risks place people with high blood pressure, diabetes, high cholesterol and heart disease in danger for serious adverse reactions that may be life threatening when taking Duro Extend Capsules with their prescriptions for their medical condition.

Duro Extend Capsules are sold across the U.S. in a blister pack containing one capsule per unit, 12-pack, 24-pack display boxes, or 3 count and 10 count bottles. All lot numbers have been recalled by Intelli Health Products.

People who have experienced an adverse reaction when using the dietary supplement should contact their physician immediately. All consumers using the product should stop using it immediately and return the unused portion to the place of purchase.

December 3, 2010

Chinese Dry Wall Lawsuits

by Burton A. Padove

A year ago, it was difficult to know who to sue for the health issues and property damage caused by defective Chinese Dry Wall located in homes across the U.S. Recently, a $2.6 million verdict came back in favor of seven Virginia homeowners who were adversely affected by Chinese Dry Wall. This verdict lays the foundation for thousands of others to receive financial compensation for the injuries they have sustained because of the dry wall. The Chinese Dry Wall lawsuit claims are being overseen by a federal judge in New Orleans. This is considered multidistrict litigation (MDL), but you can contact a local attorney if you feel you have been injured by Chinese Dry Wall.

If you have experienced serious respiratory infections, sinus infections, rashes, hair loss, hospitalization or irreparable damage to your home’s air conditioning unit, heating unit, electricity or plumbing, your damages may be linked to Chinese Dry Wall. It is not uncommon for all household members to become ill from Chinese Dry Wall.

People who live in homes with Chinese Dry Wall should evacuate because of the risk of toxicity and unknown long term side effects. There is also no viable means to remedy Chinese Dry Wall toxicity and damage, making the financial loss for property very high. It is also unknown how Chinese Dry Wall will affect the groundwater supply in areas that have homes built with this type of dry wall.

November 10, 2010

Risky Donor Blood Cells Recall

by Burton A. Padove

Recently, there have been recalls involving blood products following the discovery that the donor posed a risk injury to any individual who may receive the product. Typically, donors are screened to ensure that they are safe candidates to donate blood. It is not known why the blood products in the recall were distributed following the screening process. Given the traditional screening process, this problem does not usually occur. The following includes a list of the blood products that have been recalled in October and the reason for the recall.

LifeSource, Glenview, IL, Red Blood Cells collected from a donor who emigrated from an area considered endemic for malaria, 2 units. Recall # B-2630-10; Platelets. Recall # B-2631-10.
American Red Cross Southeastern Michigan Region, Detroit, MI Red Blood Cells Leukocytes Reduced collected from a donor for whom donor suitability was not adequately determined, 1 unit. Red Blood Cells Leukocytes Reduced. Recall # B-2586-10.

November 7, 2010

Another Dietary Supplement Recall

by Burton A. Padove

The Meredia Diet Pill has recalled by the Federal Drug Administration on October 8, 2010. Previously, the dietary supplement was banned from Europe and Australia. The drug is manufactured by Abbot Drugs, located in Lake County, Illinois. The reason for the ban and recall is because of very serious side effects associated with the drug. The drug has been known to increase the risk for cardiovascular disorders, strokes and other health issues. This is especially true in patients who had previously suffered from cardiovascular issues in the past.

Now, Acquisitions LLC dba Leiner Health Products, of Carson, CA and Marlyn Nutraceuticals, Inc., of Phoenix, AZ have announced that a large group of their dietary supplements have been recalled due to undeclared soy from a selenium chelate raw material, including:

The Lemon-Lime Flavor Effervescent Tablets Dietary Supplement, 0 tablets per box, distributed under the following names and labels:

October 27, 2010

Pats Exotic Beverages Inc. Recalls Several Beverages

by Burton A. Padove

The New York State Agriculture Commissioner has alerted consumers about Pats Exotic Beverages recall of all Carrot Juice beverages, Carrot Beet beverages, Carrot Limes beverages and Cucumber beverages. This is because it has been uncovered that the beverages have not been adequately processed and consequently, may contain harmful food pathogens.

Food borne pathogens can cause a variety of illnesses and symptoms, including: vomiting, abdominal cramps, nausea, diarrhea, fever, headaches, muscle pain, muscle weakness, or life threatening illnesses and death.

The New York State Department of Agriculture and Markets Food Inspectors discovered the risk of contamination following an inspection of Pats Exotic Beverages manufacturing processes. The department found that Pats Exotic Beverages did not have the required processes in place in order to control food pathogens. All sales of Pats Exotic Beverages have been suspended.

October 19, 2010

Recall from Wal-Mart and Kroger Stores for Frozen Peas and Mixed Veges

by Burton A. Padove

Broken glass has been found in Pictsweet’s 12 ounce frozen peas and mixed vegetables sold at Wal-Mart and Kroger stores. To date, the company suspects that 24,000 pounds of these peas and mixed vegetables have been affected. This is a voluntary recall that Pictsweet initiated to protect the public from harm. The recall was launched after the company found glass fragments in four 12 ounce packages of the frozen peas and mixed vegetables.

No injuries have been reported as of now. However, clearly the broken glass fragments could cause harm if the affected lot number of peas and mixed vegetables are eaten. It is suspected that the affected lots have reached Kroger stores in the Southeast and Wal-Mart distribution facilities located east of the Rocky Mountains. There is a chance that the affected lots of frozen vegetables have reached Wal-Mart stores. The FDA has advised that the vegetables not be eaten.

If you have any of the following lot numbers of Pictsweet peas or mixed vegetables, you are advised to contact the manufacturer about a refund.

August 27, 2010

Electronic Cigarettes Now Regulated

by Burton A. Padove

The Electronic Cigarette Association now regulates electronic cigarettes and related products to better protect the public health. These regulations will be an adjunct to the regulations offered by the FDA. In this way, additional measures to support joint objectives to help protect the public from harm.

In fact, the FDA recently sent warning letters out to five electronic cigarette distributor companies following violations of the Federal Food, Drug, and Cosmetic Act (FDCA) including unsubstantiated claims and poor manufacturing practices. According to the FDA, electronic cigarettes must be marketed in a way that meets guidelines set up by the Federal Food, Drug, and Cosmetic Act. The FDA included information about the Electronic Cigarette Association in these letters.

In order for an electronic cigarette distribution company to obtain FDA approval for operation, the company must show that the manufacturing practices of the company support safety and efficacy. The company must also demonstrate that the strength, quality and purity of the product ties in line with the safety and effectiveness needs of the FDA.

August 9, 2010

Imported Entertainment Centers by American Signature Inc. Recalled

by Burton A. Padove

Consumers who purchased entertainment center model names Arts and Crafts, Vineyard Manor, Lake Cottage, Studio One, West Indies and Plantation Cove were not aware that their $1500. plus purchase posed a risk for injury and property damage until recently. The models were sold at Value City Furniture, Rooms Today and American Signature Furniture stores from late 2002 through end of 2009.

Since then, four adverse events reports were filed, including a child whose fingers were hit by a falling shelf, an adult who had to receive stitches in their mouth and two other parties who experienced property damage- all following the fall of a shelf on the entertainment center.

The centers’ shelves can detach falling onto people or releasing objects on the center into the air or floor such as a T.V.