Consumer Lawyers

Archive for April, 2012|Monthly archive page

‘X-Rock’ male supplement recalled due to potentially hazardous ingredient

In Food Recalls on April 23, 2012 at 1:57 am

XROCK INDUSTRIES, an independent distributor of the X-ROCK products, is conducting a user level voluntary recall of certain supplement products sold by XROCK INDUSTRIES under the brand name of X-ROCK.

Finished product of X-ROCK for Men was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests conducted by the Food and Drug Administration (FDA) of X-ROCK for Men concluded that the products contained sildenafil and hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED).

Hydroxythiohomosildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. These undeclared active ingredients pose a threat to consumers because sildenafil and hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and 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 they may seek products to enhance sexual performance. Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.

All codes of X-Rock for Men, within expiration, are included in this recall. 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.

 

http://www.baynews9.com/content/news/baynews9/news/article.html/content/news/articles/cfn/2012/4/22/_x_rock_male_supplem.html

Four Indicted After They Allegedly Washed and Resold Moldy Cheese in 2007 Scheme

In Enforcement on April 23, 2012 at 1:28 am

This one makes you shake your head and ask why?

 

Four people were indicted this week on charges they washed and repackaged moldy, bacteria-laden Mexican cheese and distributed it nationally through a facility in Elmhurst, according to a press release from the Northern Illinois District of the U.S. Department of Justice.

The four allegedly ignored U.S. Food and Drug Administration orders in 2007 to hold the cheese after inspections determined that samples contained salmonella, e. coli and other dangerous bacteria.

 

According to the six-count indictment handed down on Wednesday, the Illinois company shipped 110,986 pounds of dried Mexican cheese to the Elmhurst facility over three consecutive months. The cheese was distributed to retail stores in Illinois, Indiana, Michigan, Georgia and Texas under the brand name Queso Cincho DeGuerrero. It was sold in 35- and 40-pound wheels.

On April 15, 2007, the FDA placed a hold on the first shipment, and on April 20, 2007, an FDA inspector attempted to inspect and sample the shipment at the Elmhurst facility but found that some of the cheese was missing. Leal and Gutierrez allegedly distributed 311 cartons of cheese from the April shipment prior to the April 20 inspection.

 

Read more here. http://elmhurst.patch.com/articles/four-indicted-after-they-allegedly-washed-and-resold-moldy-cheese

DMAA Lawsuit Florida April 2012

In DMAA lawsuit Florida on April 21, 2012 at 8:45 pm
Bodybuilding and dietary supplement maker BPI Sports has been hit with a class action lawsuit alleging its most popular supplements, “1.M.R.,” “RoxyLean” and “Rx6,” contain a dangerous stimulant that could kill you.

 

The BPI Sports class action lawsuit says the products are marketed for use as bodybuilding and weight-loss supplements, “However, the products contain a dangerous amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects.”
The ingredient, which is supposedly derived from the oil of the geranium plant, is known by many names, including “1,3 Dimethylamylamine” or DMAA.
According to the BPI supplement class action lawsuit, DMAA is a dangerous stimulant that has been banned by several athletic organizations, including Major League Baseball, and is completely illegal to sell in certain countries because it can fatally raise the heart rate and blood pressure of users.
DMAA was patented by Eli Lilly & Company in 1944 and later marketed under the trademark “Forthane” for use as a nasal decongestant and for treating excessive growth of oral tissue. Recently, however, DMAA has gained popularity with young people as a designer drug.

 

 

 

 

 

DMAA has been listed as an ingredient in the following products marketed as workout performance boosters at GNC outlets in military exchange stores around the world:  USPlabs Jack3d (Tropical Fruit and Lemon Lime), USPlabs OxyELITE Pro, Nutrex Research Lipo-6 Black (his and hers), Nutrex Research Lipo-6 Black Ultra Concentrate (his and hers), Nutrex Research Hemo-Rage Black Powder, Punch, Berry, iSatori PWR, Muscletech NeuroCore, Muscletech HydroxyStim, Fahrenheit Nutrition Lean EFX, Muscle Warfare Napalm, SNI Nitric Blast, BIORhythm SSIN Juice, MuscleMeds Code Red, SEI MethylHex 4,2, and Gaspari Nutrition Spirodex

 

 

 

Tunafish Recall

In Uncategorized on April 21, 2012 at 8:32 pm
  • Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 pounds of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product.
  • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores.
  • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots.
  • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak ofSalmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths.
  • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.”
  • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it.
  • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.
 
What is the Problem?
Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 pounds of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product.
 
The Nakaochi Scrape is associated with an outbreak of 116 cases of Salmonella Bareilly in multiple states: Alabama (2), Arkansas (1), Connecticut (5), District of Columbia (2), Florida (1), Georgia (5), Illinois (10), Louisiana (2), Maryland (11), Massachusetts (8), Mississippi (1), Missouri (2), New Jersey (7), New York (24), North Carolina (2), Pennsylvania (5), Rhode Island (5), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (12).
 
 
 

Hospira Announces a Nationwide Voluntary Recall of One Lot of Morphine Sulfate Injection, USP 4 MG/ML, (C-II) 1 ML Fill in 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume

In Uncategorized on April 20, 2012 at 6:43 pm

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1258-30, due to a customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume.

Opioid pain medications such as morphine have life-threatening consequences if overdosed.  Those consequences can include respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

The affected product is a prefilled glass cartridge for use with the Carpuject™ Syringe system.  The affected lot number is 10830LL. The expiration date is April 1, 2013. Morphine Sulfate Carpujects 4 mg/mL are packaged in Slim-Pak® tamper detection packages with each box containing 10 Carpujects (NDC 0409-1258-30).

The affected lot was distributed in January 2012. It was initially distributed to wholesalers and a limited number of hospitals in Arizona, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Ohio, Texas and Virginia.

Hospira has not received any reports of adverse events related to this issue for this lot. This is believed to be an isolated event, and Hospira has initiated an investigation to determine the root cause and preventive actions. Consumers should contact their physician or healthcare provider if they have experianced any problems that may be related to taking or using this product.

Anyone with an existing inventory of affected product should stop use and distribution and quarantine the product immediately and call Stericycle at 1-888-912-7088 to arrange for the return of the product. Replacement product from other lots is available.  Customers can send their DEA 222 form to Hospira, 1635 Stone Ridge Drive, Stone Mountain, GA 30083 to order replacement product.

 

http://www.fda.gov/Safety/Recalls/ucm300813.htm

Fentanyl Patch Can Be Deadly to Children

In Uncategorized on April 20, 2012 at 6:41 pm

Young children have died or become seriously ill from accidental exposure to a skin patch containing a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a safety alert to warn patients, caregivers and health care professionals about the dangers of accidental exposure to and improper storage and disposal of the fentanyl patch.

“These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future,” says Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “This reinforces the need to talk to patients and their families to make sure that these patches are stored, used and disposed of carefully.”

The fentanyl transdermal system—the patch marketed under the brand name Duragesic and available as a generic product—contains fentanyl, a potent opioid pain reliever, and treats patients in constant pain by releasing the medicine over the course of three days. (Opioids are synthetic versions of opium that are used to treat moderate and severe pain.) An overdose of fentanyl—caused when the child either swallows the patch or applies it to his or her own skin—can cause death by slowing breathing and increasing the levels of carbon dioxide in the blood.

According to Zachary A. Oleszczuk, PharmD, in FDA’s Division of Medication Error Prevention and Analysis, there have been 26 cases of accidental exposure to fentanyl since 1997, most of them involving children younger than 2 years old. There have been 10 deaths and an additional 12 cases requiring hospitalization.

 

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm

Mercury Poisoning Linked to Skin Products

In Uncategorized on April 19, 2012 at 12:46 am

Federal health officials are warning consumers not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury.

The products are marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles, says Gary Coody, national health fraud coordinator in the Food and Drug Administration’s Office of Regulatory Affairs. Adolescents also may use these products as acne treatments, adds Coody. Products with this toxic metal have been found in at least seven states.

The products are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods and online. Consumers may also have bought them in another country and brought them back to the U.S. for personal use.

 

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm294849.htm

FDA seizes contaminated ultrasound gel

In Uncategorized on April 18, 2012 at 11:50 pm

U.S. marshals seized ultrasound gel produced by a New Jersey company after the government found two dangerous strains of bacteria in the product.

The Food and Drug Administration, which announced the seizure, did not comment on how widely the gel was distributed. But it warned health-care professionals to immediately stop using the product — “Other-Sonic Generic Ultrasound Transmission” by Pharmaceutical Innovations in Newark.

 

http://www.washingtonpost.com/business/economy/fda-seizes-contaminated-ultrasound-gel/2012/04/18/gIQAaByiRT_story.html

Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Salads

In Food Recalls on April 16, 2012 at 11:41 pm

Dole Fresh Vegetables is voluntarily recalling 756 cases of DOLE® Seven Lettuces salad with Use-by Date of April 11, 2012, UPC code 71430 01057 and Product Codes 0577N089112A and 0577N089112B, due to a possible health risk from Salmonella. Dole Fresh Vegetables is coordinating closely with regulatory officials.  No illnesses have been reported in association with the recall.

The Product Code and Use-by Date are in the upper right-hand corner of the package; the UPC code is on the back of the package, below the barcode. The salads were distributed in fifteen U.S. states (Alabama, Florida, Illinois, Indiana, Maryland, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin).

No illnesses have been reported in association with the recall. This precautionary recall notification is being issued due to an isolated instance in which a sample of Seven Lettuces salad yielded a positive result for Salmonella in a random sample test collected and conducted by the State of New York.

No other Dole salads are included in the recall. Only the specific Product Codes, UPC codes and April 11, 2012 Use-by-Date of Seven Lettuces salads identified above are included in the recall. Consumers who have any remaining product with these Product Codes should not consume it, but rather discard it. Retailers and consumers with questions may call the Dole Food Company Consumer Response Center at (800) 356-3111, which is open 8:00 am to 3:00 pm (PDT) Monday – Friday.

Retailers should check their inventories and store shelves to confirm that none of the product is mistakenly present or available for purchase by consumers or in warehouse inventories. Dole Fresh Vegetables customer service representatives are already contacting retailers and are in the process of confirming that the recalled product is not in the stream of commerce.

 

http://www.fda.gov/Safety/Recalls/ucm300414.htm

Maine Firm Recalls Ground and Tenderized Beef Products Due to Possible E. Coli O157:H7 Contamination

In Food Recalls on April 16, 2012 at 11:39 pm

Town and Country Foods Inc., a Greene, Maine establishment, is recalling approximately 2,057 pounds of ground and tenderized beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced.

 

Each case bears a label with the establishment number “EST. 9710” inside the USDA mark of inspection. Additionally, the products contain the following packaging codes: 10952, 10962, 10972, 11002, and 11012. The products subject to recall were produced between April 4, 2012 and April 10, 2012 and were shipped to wholesale and retail establishments in Maine. When available, the retail distribution list(s) will be posted on FSIS’ website at www.fsis.usda.gov/FSIS_Recalls/Open_Federal_Cases/index.asp.

 

http://www.fsis.usda.gov/News_&_Events/Recall_024_2012_Release/index.asp