Dayton Personal Injury Lawyer - FDA & Prescription Drugs

P&G Recalls Sinex Nasal Spray

Chrissie Cole — Sat, 21 Nov 2009 00:17:00 GMT

Three lots -- about 120,000 bottles -- of Vicks Sinex nasal spray has been voluntarily recalled by Proctor & Gamble in three countries after bacteria B. cepacia was detected during routine testing.

While there have been no reports of illness, the bacteria can cause serious infections for those individuals with a compromised immune system or chronic lung condition, said P&G in a news release. However, in healthy people, the risk is relatively low.

Consumers should contact P&G for a refund or replacement coupon.

The nasal sprays were sold in three markets and are outlined below:

In the U.S.: 9239028831 - Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist

In the U.K.: 9224028832 - Vicks Sinex Micromist Aqueous Nasal Spray Solution

In Germany: 9224028833 - Wick Sinex Schnupfenspray Dosiersystem

Originally posted at InjuryBoard by Chrissie Cole

Flour Tortillas Recalled By Pop's Bakery

Chrissie Cole — Tue, 27 Oct 2009 14:53:00 GMT

Pop’s Bakery, of Texas, announced a voluntary recall of all flour tortillas because they contain undeclared whey (milk). People who have an allergy to whey run the risk of serious or life-threatening allergic reaction if these products are unknowingly consumed.

To this date, there have been no illnesses associated with the recall.

The following number codes are included in the recall:

110609, 110509, 110409, 110309, 110209, 110109, 103109, 103009, 102909, 102809, 102709, 102609, 102509, 102409, 102309, 102209, 102109, 102009, 101909, 101809, 101709, 101609, 101509, 101409, 101309, 101209, 101109, 101009, 100909, 100809, 100709.

The recalled tortillas were distributed within the state of Texas to restaurants and grocery stores. The product label says “POP’S BAKERY HOME STYLE FLOUR TORTILLAS.”

Consumers are urged to contact the company directly with any questions at 1-325-655-1170 or 1-325-374-5392 during the hours of 9:00 am – 3:00 pm Monday through Thursday.

Originally posted at InjuryBoard by Chrissie Cole

Certain Tylenol Liquid Products Recalled

Chrissie Cole — Thu, 24 Sep 2009 14:44:00 GMT

Johnson & Johnson’s McNeil unit is voluntarily recalling 57 lots of Children’s Liquid Tylenol Products because they may have bacterial contamination.

According to the company, one of the inactive ingredients tested positive for Burkholderia cepacia or B. cepacia. However none of the bacteria was found in the finished product. The likelihood of a serious medical event is minimal, but after consulting with the FDA, the company agreed to recall the products.

The recalled brands include Children’s Tylenol Suspension 4 ounce Strawberry, Children’s Tylenol Pediatric Suspension 1 ounce Cherry, and Infant’s Tylenol Suspension Drops ½ ounce Grape.

Additional Information: Consumers should contact McNeil's consumer call center at 1-800-962-5357 with further questions.

View a full list of 21 recalled Tylenol products and their corresponding lot numbers.

Originally posted at InjuryBoard by Chrissie Cole

Melon Acres Recalls Canteloupes for Possible Salmonella Risk

Chrissie Cole — Sat, 29 Aug 2009 11:10:00 GMT

Melon Acres recalled cantaloupes at several Midwest locations including Greenwood, Indiana, Lansing, Michigan, and Tipp City, Ohio due to a possible risk of salmonella contamination.

The recall was announced August 27 on the U.S. Food and Drug Administration (FDA) Web site.

As of this date, no illnesses have been associated with the recalled cantaloupe, according to the news release.

The agency tested the melons on August 11. They found one of twenty tested positive for salmonella. The findings were reported to Melon Acres on August 21.

Salmonella is frequently the culprit behind food-borne illnesses. Symptoms of salmonella contamination include fever, diarrhea, nausea, vomiting, and abdominal pain. Generally, symptoms appear within 12 hours to 72 hours of eating tainted food. Infants, the elderly, and those with weakened immune systems are more likely than others to develop severe illness.

Originally posted at InjuryBoard by Chrissie Cole

Kid's Multivitamin Recalled For Label Error

Chrissie Cole — Thu, 11 Jun 2009 07:04:00 GMT

Food Science Corp. announced a voluntary recall of about 1,250 bottles of its Children’s Multivitamins due to an error on the labels’ regarding suggested use.

When consumed as directed, this product could pose a health risk if taken for an extended period of time, although the risk is minimal.

The recalled vitamins are marketed under the following brands:

DaVinci Laboratories of Vermont Kid's Mighty Vites (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311 and 6988100 0311

FoodScience of Vermont Kids Superior (90 tablet bottle) Lot #s 6741500 0311 and 6741600 0311and 6988100 0311 and 7198100 0311

Mountain Naturals of Vermont Kid's Superior (90 tablet bottle) Lot #s 6741700 0311

Sherlock Vitamins Smart Strong Focus (60 tablet bottle): Lot # 6747900 0311

Elders International, Inc. M10-8® Kids IQ Secret (90 tablet bottle): Lot # 6830700 0311

Guyer Institute HEALTHY KIDS MV (90 tablet bottle): Lot # 6784400 0311

The products were distributed throughout the U.S., Denmark, Kenya, New Zealand, retail stores and doctors from March 12 through June 3, 2009.

To date, there have been no reported adverse events associated with the recalled products.

Consumers should return the recalled vitamins to the store of purchase for a free refund. For recall assistance, questions and concerns can be directed to the company at 1-800-451-5190.

Originally posted at InjuryBoard by Chrissie Cole

FDA - The Nuthouse Recalls Pistachios

Chrissie Cole — Fri, 08 May 2009 12:08:00 GMT

The Food and Drug Administration (FDA) is warning consumers that The Nuthouse is recalling 5 lb boxes and bags of pistachios because they may be contaminated with Salmonella.

The company is recalling the items as a precautionary measure following a recall of all roasted & salted in-shell pistachios by Setton Pistachio of Terra Bella, Inc.

Salmonella poisoning occurs when a person consumes food contaminated with the bacteria. The illness causes flu-like symptoms including diarrhea, fever and abdominal cramps. These symptoms usually begin 12-72 hours after infection, and will typically last up to a week.

In rare cases, Salmonella poisoning can cause serious illness and produce more severe illnesses such as arterial infections, endocarditis, and arthritis.

To date there has not been any reports of illness in conjunction with the recalled items.

Consumers that may have purchased any recalled pistachios from the Nuthouse can contact the company at 213.623.2541 between 9:00 AM and 4:00 PM pacific time.

Originally posted at InjuryBoard by Chrissie Cole

Contaminated Heparin Seized By FDA

Chrissie Cole — Sat, 08 Nov 2008 14:50:00 GMT

The U.S. Food and Drug Administration (FDA) recently seized 11 lots of heparin from Celsus Laboratories Inc., in Cincinnati, Ohio.

U.S. Marshals seized five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium. The agency found the products, manufactured from material imported from China, to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that imitates heparin’s blood thinning activity.

Heparin sodium, is an injectable anticoagulant that is used to prevent blood from clotting in patients who undergo certain medical procedures. The drug was the center of a major recall initiated in January after crude material from China was found to be contaminated.

To date, the FDA has initiated 13 recalls of numerous contaminated products containing heparin from several companies. 250 deaths have been linked to the contaminated product and hundreds of patients have suffered serious adverse events.

The agency seized the contaminated heparin products after the company failed to adequately notify customers of the product contamination, stemming from an April investigation.

Originally posted at InjuryBoard by Chrissie Cole

Public Citizen Petitions FDA for Ban Of Avandia

Chrissie Cole — Fri, 31 Oct 2008 22:47:00 GMT

Public Citizen, a non-profit group, is petitioning the U.S. Food and Drug Administration (FDA) for an immediate ban of the drug Avandia because the drug can cause death from liver failure and other serious life-threatening risks that far outweigh its benefits.

Avandia, also known by its generic name, rosiglitazone or rosiglitazone maleate, manufactured by GlaxoSmithKline, is prescribed by doctors for the treatment of type 2 diabetes.

While reviewing FDA data, the group discovered 14 unpublished cases of severe drug-induced liver failure, which included 12 deaths.

That risk, as well as other well known health complications associated with Avandia including heart failure, vision loss and bone fractures, was too great to allow marketing of the drug to continue in the U.S., especially while other, safer treatments remain available, the group said in its petition to the FDA.

“The scientific evidence against Avandia is staggering,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These findings should give the FDA the push they need to act quickly to prevent any further needless deaths and health damage caused by this drug.”

Originally posted at InjuryBoard by Chrissie Cole

Lucky Country Recalls Natural Black Licorice Products

Chrissie Cole — Sat, 06 Sep 2008 23:18:00 GMT

Lucky Country Inc., announced a voluntarily recall of all its natural black licorice products due to excessive levels of lead.

Recent tests conducted by the California Department of Public Health and the U.S. Food and Drug Administration (FDA) found Lucky Country Aussie Style Soft Gourmet Licorice Black (All Natural) in 1.5 lb bags contained lead levels exceeding what is permitted in candy.

Also included in the recall are 6 oz bags, 3 lb bags and a 1 lb tub. Consumers are advised to discard any recalled products or return them to their nearest retail outlet to receive a full refund.

For more information, consumers can contact the company at customerservice@lucky-country.com, or 828 428-8313 during business hours.

The candy was sold in the following states: California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Minnesota, New Hampshire, Pennsylvania, Utah, Virginia and Washington State.

Originally posted at InjuryBoard by Chrissie Cole

Little Bay Baking Company Issues Nationwide Allergy Alert

Chrissie Cole — Fri, 02 May 2008 08:10:00 GMT

Little Bay Baking Company announced a voluntary recall of Corn Bread and Muffin Mix that was sold before May 2, 2008 because it contains undeclared soy. People who may have a severe sensitivity or allergy to soy are at risk of developing a serious or life threatening allergic reaction if they consume these products unknowingly.

The Corn Bread and Muffin Mix was distributed throughout the United States via internet orders and in retail stores. The products are available in 12.6 ounce white paper tin tie bag packages sole under the names Little Bay Baking and GFCF Diet.

To date, the company has not received any reports of illness.

The recall was prompted after it was discovered that the mixes containing possible traces of soy was distributed but the packaging failed to reveal any presence of soy. A preliminary investigation indicates the problem was caused by a temporary breakdown in the company’s ordering process.

Consumers can return the recalled product directly to the company. For more information they can be contacted at 1-603-828-7236.

Originally posted at InjuryBoard by Chrissie Cole