Consumer Lawyers

Archive for August, 2012|Monthly archive page

True Nutrition Recalls Whey Protein Products for Undeclared Milk

In FDA Warning on August 28, 2012 at 2:26 pm

True Nutrition is recalling some of its whey protein products because labels do not declare milk as the source of the whey. Milk is one of the major food allergens. Anyone who is allergic to milk and consumes these products may have a severe or life-threatening reaction. You can see all of the product labels at the FDA site.

The products are: Whey Protein Concentrate in 1 pound packages, with Batch/lot number 0120712, and expiration date of 05/2015. Whey Protein Isolate Cold-Filtration in 1 pound packages, with Batch/lot number 0030812 and expiration date 07/2015. Whey Protein Isolate MicroFiltrated in 1 pound packages, with Batch/lot number 0040812 and expiration date 07/2015. Whey Protein Isolate Cross-Flow Microfiltration in 1 pound packages with Batch/lot number 0730712 and expiration date 07/2015. And Hydrolyzed Whey Protein High Grade in 1 pound packages with Batch/lot number 0680512 and expiration date 05/2015.

 

http://foodpoisoningbulletin.com/2012/true-nutrition-recalls-whey-protein-products-for-undeclared-milk/

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FDA Health hazard alert: Recall on black licorice

In Food Recalls on August 28, 2012 at 2:25 pm

American Licorice Company recalling the 16 oz. bags of Red Vines Black Licorice Twists. The recall is due to the discovery of elevated levels of lead contained in the licorice. The one pound bags are affected by this recall. American Licorice is notifying consumers and customers to discard this product and to not consume.

The American Licorice Company learned of these high lead levels from the California Department of Public Health (CDPH). The contents could potentially cause health problems to consumers, particularly infants, small children, and pregnant women.

 

http://www.examiner.com/article/fda-health-hazard-alert-recall-on-black-licorice

FDA recalls another CareFusion infusion pump

In Product Recalls on August 28, 2012 at 2:23 pm

U.S. health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death.

The U.S. Food and Drug Administration said the affected pump modules, used for delivering a variety of fluids, drugs and blood products to patients, were manufactured between October 2011 and February 2012.

The FDA classified the action as a Class I recall on its website, meaning that the defective units could cause serious harm to a patient’s health.

Read more: http://www.foxnews.com/health/2012/08/23/fda-recalls-another-carefusion-infusion-pump/#ixzz24qoamjlh

Lap-Band weight loss firm warned about ads

In Uncategorized on August 27, 2012 at 8:52 pm

he Food and Drug Administration has warned a Los Angeles-based Lap-Band firm to pull misleading weigh loss surgery ads.

The FDA letter to Lap-Band VIP in suburban Encino tells the owners to change their billboard and television marketing or they will face disciplinary action.

It’s the second California Lap-Band firm to get a warning. The agency warned 1-800-GET-THIN in December.

 

Read more here: 

he Food and Drug Administration has warned a Los Angeles-based Lap-Band firm to pull misleading weigh loss surgery ads.

The FDA letter to Lap-Band VIP in suburban Encino tells the owners to change their billboard and television marketing or they will face disciplinary action.

It’s the second California Lap-Band firm to get a warning. The agency warned 1-800-GET-THIN in December.

FDA Warns Again on Painkiller Supplement – Reumofan Plus

In Product Recalls on August 27, 2012 at 8:48 pm

The FDA has issued a new warning against a Mexican “natural” dietary supplement marketed for pain relief due to unlabeled and potentially harmful drug ingredients.

Ongoing lab analysis of the supplements found that Reumofan Plus and Reumofan Plus Premium contain at least three unlabeled drug ingredients, including:

  • Dexamethasone: a corticosteroid that can cause withdrawal syndrome if discontinued after long periods of use or high doses
  • Diclofenac sodium: a nonsteroidal anti-inflammatory drug (NSAID) that can increase risk of serious cardiovascular and gastrointestinal events
  • Methocarbamol: a muscle relaxant that can cause sedation, dizziness, hypotension, and impaired mental and physical abilities

 

The agency issued an initial warning against the products in June, 2012, due to adverse event reports that included incidents of liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression. Since that warning was issued, the FDA has received reports of severe bleeding and withdrawal syndrome, the agency said in a statement issued Tuesday.

 

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/34323

Zest Garden Recalls Wilson & Fisher Bistro Sets Due to Fall Hazard

In Product Recalls on August 27, 2012 at 8:45 pm

News from the CPSC:

 

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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of product: Wilson & Fisher White Cast Bistro Table and Chairs Set

Units: About 22,500

Retailer: Big Lots, of Columbus, Ohio

Importer: Zest Garden, of Ontario, Calif.

Hazard: The chairs can break during normal use, posing a fall hazard to consumers.

Incidents/Injuries: Zest Garden has received five reports of chairs breaking, including three reports of injuries.

Description: This recall involves three-piece patio sets sold in a white, cut-out rose pattern. The set consists of a table and two chairs made of cast iron and aluminum. The table is about 26 inches high and measures about 24 inches in diameter. Each chair is about 33 inches high with an oval-shaped seat that measures about 19 inches long and about 16 inches wide. The item number is XG-1015-23. The product measurements, the item number and “Wilson & Fisher White Cast Bistro Set” and “Made in China” are printed on labels located on the product’s packaging.

Sold exclusively at: Big Lots stores nationwide from November 2011 to May 2012 for about $100.

Manufactured in: China

Remedy: Consumers should immediately stop using the set and return it to any Big Lots store for a full refund.

Consumer Contact: For more information, contact Zest Garden at (800) 893-3006 between 9 a.m. and 5 p.m. PT, Monday through Friday, or send an e-mail toinfo@zestgarden.com, or visit the firm’s website at www.biglots.com

Pure Hothouse Foods Inc. : Recall of Fresh Cut Grilling Trays Because of Possible Health Risk

In Product Recalls on August 24, 2012 at 3:18 pm

Pure Hothouse Foods Inc.  is recalling a total of 1402 cases and 8,412 individually distributed units of fresh cut grilling trays, as listed below, with the Sell by dates of August 11th, 2012 through August 26, 2012 because they contain whole or sliced mushrooms which may be contaminated with Listeria monocytogenesListeria monocytogenes is an organism that can cause serious or life-threatening food borne illness in a person who eats a food item contaminated with it. Symptoms of infection may include fever, muscle aches, gastro intestinal symptoms such as nausea or diarrhea. The illness primarily impacts pregnant women and adults with weakened immune systems. Most healthy adults and children rarely become seriously ill.

The voluntary recalled products were produced and distributed from Pure Hothouse Foods Inc. in Leamington, Ontario, Canada to retailers in the following states: Michigan, Ohio, Indiana, Illinois, and Kentucky.

This voluntary recall notification is being issued due to finding Listeria monocytogenes in finished product that contained mushrooms. Pure Hothouse Foods Inc. is coordinating closely with regulatory officials.

No illnesses have been reported in association with this voluntary recall.

Pure Hothouse Foods Inc. customer service representatives have already contacted all customers impacted and are in the process of confirming that the recalled products are not in the stream of commerce. Consumers with questions may contact Pure Hothouse Foods Inc. directly at 1-866-326-8444 M-F 8am-5pm. (Eastern Standard Time)

Product Description Use by Date UPC Code
Meijer Brand “Grillers Mushroom with Rosemary” August 11th – August 26th 2012 7-08820-85464-2
Meijer Brand “Grillers Steak Topper” August 11th – August 26th 2012 7-08820-85468-0
Meijer Brand “Grillers Asparagus Blend” August 11th – August 26th 2012 7-08820-85353-9

Only the specific products identified in the list above are included in this precautionary voluntary recall. Retailers should check their inventories and store shelves to confirm that none of the product is present or available for purchase by consumers or in warehouse inventories.

Ampyra (dalfampridine): Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients

In Uncategorized on August 24, 2012 at 2:56 pm

While not a recall notice, this is nonetheless important information for consumers from the FDA:

 

SSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine).  The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures. The FDA is updating the Ampyra drug label to clarify recommendations.

BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug.  Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk. 

RECOMMENDATION: FDA reminds health care professionals that there are age-related decreases in renal function, and mild renal impairment is common after age 50, even when serum creatinine is normal.  Renal function should be assessed by estimating creatinine clearance. Ampyra should not be used in patients with a history of seizures or who have moderate to severe renal (kidney) impairment (measured as creatinine clearance [CrCl] less than or equal to 50 mL/min).

Additional information for Patients includes:

  • Tell your health care professional if you have kidney problems.
  • Your health care professional should order blood tests periodically to evaluate your kidney function.
  • Do not take Ampyra if you have ever had a seizure.
  • Ampyra tablets should be taken whole and not divided, crushed, chewed, or dissolved.
  • Do not take double or extra doses of Ampyra if a dose is missed.  Side effects, including seizures, are more frequent at higher doses.

Additional information for Health Care Professionals includes:

  • Ampyra is contraindicated in patients with a history of seizures or with moderate to severe renal impairment (CrCl < 50 mL/min).
  • The potential benefits of Ampyra treatment should be carefully considered against the risk of seizures before using Ampyra in patients with mild renal impairment (CrCl 51-80 mL/min).
  • A patient’s CrCl (calculated using the Cockroft-Gault equation) should be known before initiating Ampyra treatment and monitored at least annually whileAmpyra treatment continues, even when serum creatinine levels appear to be normal.
  • Tell patients they should not take double or extra doses of Ampyra if a dose is missed.  Adverse effects, including seizures, are more frequent at higherdoses.
  • Ampyra should be discontinued permanently if a seizure occurs.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch

Synthes recalls certain lots of bone putty

In Product Recalls on August 24, 2012 at 2:54 pm

SSUE: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.

BACKGROUND: Hemostatic Bone Putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The affected models and lot numbers can be found in the FDA Recall Notice.

RECOMMENDATION: On July 5, 2012, Synthes issued a Medical Device Recall letter requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the Hemostatic Bone Putty.

If a facility had the affected product in stock, they were asked to call 1-800-479-6329 to obtain a Return Authorization Number, complete the verification form and return both the form and identified product to Synthes.

California Firm Recalls Grilled Chicken Caesar Salad Kits For Possible Salmonella Contamination

In Uncategorized on August 23, 2012 at 9:51 pm

Real Mex Foods, a Vernon, Calif. establishment, is recalling approximately 77,688 pounds of Grilled Chicken Caesar Salad Kits. The salad kits include dressing made with cilantro that is the subject of a Food and Drug Administration (FDA) recall by Fresco Green Farms Inc., due to possible Salmonella contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall are: [View Label]

  • 36-oz. trays of “El Torito Grilled Chicken Caesar Salad Kit.”
  • 18-lb. cases that contain eight (8) 36-oz. trays of “EL TORITO Grilled Chicken Caesar Salad Kit.

The products subject to recall bear the establishment number “P-4140” inside the USDA mark of inspection. The cases bear any of the following sell by dates: “08/23/12,” “08/30/12,” “09/06/12,” or “09/14/12.” The trays bear the same sell by dates in the following format: “082312,” “083012,” “090612,” or “091412.” Each case is also marked with an identifying item number of “24203.” The products were produced between July 23, 2012, and August 6, 2012, and distributed to retail establishments in California. When available, the retail distribution list will be posted on FSIS’ website atwww.fsis.usda.gov/
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