Wednesday, November 14, 2012

Powermate Generators Recall to Repair by Pramac America Due to Fire Hazard; Sold Exclusively at Home Depot


Name of Product: Powermate Sx 5500 portable generators
Units: About 7700
Importer: Pramac America LLC, of Kearney, Neb.
Manufacturer: Am Pride Chongqing Senci IMP & EXP Trade Co., of China
Hazard: The fuel filter on this generator allows gasoline to leak, posing a fire hazard.
Incidents/Injuries: Pramac America has received 51 reports of fuel filter leakage. No fires or injuries have been reported.
Description: The recalled portable generators have "Powermate 5500" printed on the side of the black generator with wheels. These generators were sold under the model name Sx5500 and model number PM0125500. Both are printed on a plate on the rear of the generators with serial numbers of the recalled units ranging from K003xxxxxQ through K090xxxxxQ.
Sold exclusively at: Home Depot stores in northeast, mid-west and southeast United States from February 2012 through August 2012 for about $550.
Manufactured in: China
Remedy: Consumers should stop using these recalled portable generators and contact Pramac America to receive a free repair kit including a replacement filter, hose and hose clamps for fuel line.
Consumer Contact: Pramac America LLC at (800) 445-1805 from 7 a.m. to 5 p.m. CT Monday through Friday or www.powermate.com and click on the Generator tab and then the Expert Advice followed by the Service Notification link for more information.

Powermate Generator w/fuel filter identification
Powermate Generator w/fuel filter identification



Rear view of Powermate Generators

Rear view of Powermate Generators



Powermate information plate on rear of generator

Powermate information plate on rear of generator


Powermate Generators Recall to Repair by Pramac America Due to Fire Hazard; Sold Exclusively at Home Depot

Thursday, November 8, 2012

Undeclared Sulfites In Fu Xiang Yuan Trading Inc "Lily Dry"


Consumer Alert - Undeclared Sulfites In Fu Xiang Yuan Trading Inc "Lily Dry"


Contact
Consumer:
917-642-8322

Media:
Joe Morrissey
518-457-0752
Joe.Morrissey@agriculture.ny.gov
FOR IMMEDIATE RELEASE - November 7, 2012 - New York State Agriculture Commissioner Darrel J. Aubertine today alerted consumers that Mayflower International Inc, aka Fu Xiang Yuan Trading Inc, located at 220 Ingrahm St. in Brooklyn, NY, is recalling Fu Xiang Yuan Trading Inc brand “Lily Dry” due to the presence of undeclared sulfites. No illnesses have been reported to date to this Department in connection with this product.
The recalled Fu Xiang Yuan Trading Inc brand “Lily Dry” is packaged in a 3.5 oz. (100 gram) plastic and foil bag. There is a UPC code of 6-944295-300176 located on the back of the package but there is no other coding on the product. The product was distributed throughout the United States and is a product of China.
Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites which were not declared on the label. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. In addition, the consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.
Consumers who have purchased the Fu Xiang Yuan Trading Inc brand “Lily Dry” should contact Liu Min at 917-642-8322.

 Lily Dry 3.5 oz 100g Label Front

Consumer Alert - Undeclared Sulfites In Fu Xiang Yuan Trading Inc "Lily Dry"

Thursday, October 25, 2012

Dog treats recalled because of possible salmonella poisoning


Kasel Associated Industries of Denver is voluntarily recalling their Boots & Barkley Roasted American Pig Ears and Boots & Barkley American Variety Pack dog treats because they may be contaminated with salmonella.
The recalled roasted pig ears and variety pack dog treats were distributed nationwide through Target stores in August 2012.

The lot number being recalled is stamped with BESTBY 13SEP2014DEN on both products. The recall stems from the lot testing positive for salmonella bacteria by the Colorado Department of Agriculture.
The roasted pig ears are sold in a clear plastic bag that contain 12 pig ears and have UPC bar code 647263899158. The variety pack is sold in a 32-ounce clear plastic bag and has UPC bar code 490830400086.
Both animals and humans are at risk of getting salmonella poisoning. Animals can get sick from eating the treats while humans can get sick from handling the contaminated treat, especially if their hands are not washed immediately after handling the products.
Signs that your animal could have salmonella poisoning include acting lethargic, have diarrhea or bloody diarrhea, a fever and vomiting. Some animals may only have a decreased appetite, fever or abdominal pain. There is a possibility that your animal is healthy and will not be affected by the salmonella poisoning, but they can still pass it on to other animals or humans. If you think your pet is infected, call your veterinarian.
Humans are also able to contract salmonella poisoning and should look for the following signs if they have handled the infected treats: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and a fever. If you think you could be infected, contact your healthcare provider.
There have been no illnesses reported in connection to this product to date, and no other products made by Kasel Associated Industries are included with this recall.
If you have purchased the roasted pig ears or variety pack dog treats, you are urged to return them to the place of purchase for a full refund.
If you have further questions you can contact Kasel Associated Industries at 800-218-4417 Monday through Friday from 7 a.m. to 5 p.m. MDT.


Dog treats recalled because of possible salmonella poisoning - CBS 5 - KPHO

Monday, October 15, 2012

Voluntary Recall of Select Packages of Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size


Contact:
Consumer:
800-962-1413

 
FOR IMMEDIATE RELEASE - October 8, 2012 - We have initiated a voluntary recall due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part. Recalled products include only Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size with the letters KB, AP or FK before or after the Best If Used Before date. Products impacted are:
Kellogg's Frosted Mini-Wheats Bite Size Original cereal
  • UPC 3800031829 - 18-ounce carton with Better if Used Before Dates between APR 01 2013 KB - SEP 21 2013 KB
  • UPC 3800073444 - 18-ounce carton with Better if Used Before Dates between APR 01 2013 KB - SEP 21 2013 KB
  • UPC 3800031834 - 24-ounce carton with Better if Used Before Dates between APR 01 2013 KB - SEP 21 2013 KB
  • UPC 3800046954 - 30-ounce carton with Better if Used Before Dates between APR 01 2013 KB - SEP 21 2013 KB
  • UPC 3800031921 - 70-ounce club store carton with Better if Used Before Dates APR 01 2013 KB - JUL 29 2013 KB
  • UPC 3800004961 - single-serve bowl with Better if Used Before Dates between 04013 KB - 09213 KB
  • UPC 3800021993 - single-serve carton with Better if Used Before Dates between AP 04013 - AP 09213 or FK 04013 - FK 09213
Kellogg's Mini-Wheats Unfrosted Bite Size cereal
  • UPC 3800021983 - single serve carton with Better if Used Before Dates between FK 04013 - FK 09213
  • UPC 3800035982 -18-ounce carton with Better if Used Before Dates between APR 01 2013 KB - SEP 21 2013 KB
Consumers with affected product or who have questions should contact us using the Contact Us feature on Kelloggs.com or call 800-962-1413 from 8 am to 6 pm Eastern Time, Monday - Friday.

Recalls, Market Withdrawals, & Safety Alerts > Voluntary Recall of Select Packages of Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size

Friday, October 12, 2012

Crunchy: Kellogg's recalling Mini-Wheats because of metal in boxes - Local News - Anchorage, AK | NBC News

Kellogg's Mini-Wheats are a little crunchier than usual. And that's not a good thing.
Kellogg's has issued a recall of nearly 3 million boxes of its Bite Size Frosted and Unfrosted Mini-Wheats cereal because of a manufacturing problem that left some packages contaminated with bits of metal.
Yup: Bits of metal. Not exactly the breakfast of champions.
"We have initiated a voluntary recall due to the possible presence of fragments of flexible metal mesh from a faulty manufacturing part," the company said in a statement. "Recalled products include only Frosted Mini-Wheats Bite Size Original and Mini-Wheats Unfrosted Bite Size with the letters KB, AP or FK before or after the Best If Used Before date."
The boxes have "use by" dates between April 1 and Sept. 21 of next year. The recalled cereal was distributed nationwide.
This is the second national recall in just over two years for Kellogg's, maker of dozens of cereals as well as Pop Tarts and Eggo Waffles.
In 2010, Kellogg's recalled Fruit Loops, Corn Pops, Apple Jacks and Honey Smacks cereals because of a funky smell and flavor attributed to a packaging issue.

You can score a replacement box of cereal -- presumably with a lower quotient of metal -- by calling (800) 962-1413.


Crunchy: Kellogg's recalling Mini-Wheats because of metal in boxes - Local News - Anchorage, AK | NBC News

Monday, October 1, 2012

FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Possibly Linked to Trader Joe's Valencia Creamy Salted Peanut Butter

FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Possibly Linked to Trader Joe's Valencia Creamy Salted Peanut Butter
Posted October 1, 2012 
UPDATE: List of Recalled Products
On this page:
UPDATE:  October 1, 2012
There have been a number of recalls related to the expanded Sunland Inc. recall of products which include peanut butter and other products made with nuts and seeds. Among those companies initiating related recalls are Chattanooga Bakery Inc., Fairytale Brownies, Falcon Trading Company/SunRidge Farms, Giant Food, disclaimer icon  Gretchen Shoebox Express, Harry and David, Jer's Chocolates, Justin's, Late July Snacks, Newman's Own Organics disclaimer icon , Oregon Ice Cream Company, Stop & Shop Supermarket Company and Whole Foods Market.

The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multi-state outbreak of Salmonella Bredeney infections. We are moving quickly to learn as much as possible and prevent additional people from becoming ill. We recognize that people will be concerned about this outbreak, and we will continue to provide updates and advice.
What is the Problem and What is Being Done?
The FDA’s top priority is protecting consumers and ensuring the safety of our food supply. The FDA, the Centers for Disease Control and Prevention and state and local public health officials are investigating a multi-state outbreak of Salmonella Bredeney infections possibly linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, with a Stock Keeping Unit (SKU) identifier of 97111. The Centers for Disease Control and Prevention (CDC) reports a total of 30 people infected with the outbreak strain of Salmonella Bredeney from 19 states.
Once FDA became involved in this fast-moving outbreak investigation, we began coordinating and working closely with the CDC and several state health departments, which have been leading their own investigations.  On September 20, FDA, the CDC and the state of California briefed Trader Joe’s on the status of the investigation, and the company volunteered to remove the suspected product from their store shelves. Trader Joe’s has also posted a customer advisory on their internet page and initiated a recall.
As part of its investigation, FDA contacted Sunland Inc., which makes Trader Joe’s Valencia Creamy Salted Peanut Butter.  On September 23, FDA and CDC briefed Sunland Inc. on the status of the investigation and the company volunteered to recall the almond butter and peanut butter products that were manufactured on the same product line as Trader Joe’s Valencia Creamy Salted Peanut Butter between May 1 and September 24, 2012.
On the evening of September 24, Sunland Inc. expanded their recall to about 100 products, which include peanut butter and other products made with nuts and seeds. A list of those products can be found in the company's recall announcement. 
As the investigation progresses we will keep the public informed.
What Do Consumers Need To Do?
Consumers should not eat the recalled products. This is especially important for children under the age of 5 years, elderly adults, and people with weak immune systems. Consumers should dispose of the product or return the product to the store where they purchased it.
What is Being Recalled?
Trader Joe’s Valencia Creamy Salted Peanut Butter is sold at Trader Joe's grocery stores nationwide and on the internet. Sunland Inc. products are distributed nationally via supermarket chains.
As a convenience, FDA has provided a list of products recalled by Sunland Inc., as found on the company’s press releases. The recall is limited to the products listed below that have “Best-If-Used-By” dates between May 1, 2013 and September 24, 2013. The “Best-If-Used-By” dates are stamped on the side of the jar’s label below the lid. Sunland Inc. has advised consumers to return the product to the supermarket of purchase or to dispose of it.
Please see the company's recall announcement for the most updated list of recalled products.
UPC
Type of product
Jar Size
8523902336
Archer Farms Almond, Peanut & Cashew Butter
16 oz
8523902334
Archer Farms Creamy Almond Butter
16 oz
8523920335
Archer Farms Creamy Cashew Butter
16 oz
8523902333
Archer Farms Peanut Butter with Flax Seeds
16 oz
26704
Creamy Sugar Butter
5 lb
25704
Crunchy Sugar Butter
5 lb
003050
Dogsbutter RUC with Flax PB
16 oz
3377610090
Earth Balance Natural Almond Butter and Flaxseed
16 oz
20003395
fresh & easy Creamy Almond Butter
16 oz
051379022525
fresh & easy Creamy Cashew Butter
16 oz
20003364
fresh & easy Creamy Peanut Butter
18 oz
051379026431
fresh & easy Creamy Peanut Butter
40 oz
003248
fresh & easy Creamy Peanut Butter Cups
72/2 0z
051379022518
fresh & easy Crunchy Almond Butter
16 oz
20003371
fresh & easy Crunchy Peanut Butter
18 oz
051379041625
fresh & easy goodness valencia Creamy Peanut Butter
12/8 1.1 oz cups in a carton
20003357
fresh & easy Organic Creamy Peanut Butter with Sea Salt
16 oz
20003357
fresh & easy Organic Creamy Peanut Butter with Sea Salt
16 oz
20003388
fresh & easy Organic Crunchy Peanut Butter with Sea Salt
16 oz
8099473871
Harry & David Creamy Banana Peanut Spread
12 oz
8099473872
Harry & David Creamy Raspberry Peanut Spread
12 oz
8099473873
Harry & David Crunchy Almond and Peanut Butter
12 oz
2060140048
heinen's All Natural Peanut Butter, Creamy
16 oz
2060140047
heinen's All Natural Peanut Butter, Crunchy
16 oz
2060140046
heinen's Organic Peanut Butter, Creamy
16 oz
2060140045
heinen's Organic Peanut Butter, Crunchy
16 oz
3307915072
Joseph's Salt-Free No Sugar Added New Creamy Valencia Peanut Butter
18 oz
3307915073
Joseph's Salt-Free No Sugar Added New Crunchy Valencia Peanut Butter
18 oz
910053
Natural Value Creamy Peanut Butter/Salt
15 lb
910060
Natural Value Crunchy Peanut Butter/Salt
15 lb
5859500019
Naturally More Almond Butter
16 oz
5859500020
Naturally More Organic Peanut Butter
16 oz
5859500033
Naturally More Peanut Butter Crunchy
16 oz
5859500050
Naturally More Peanut Butter, Gluten Free Vegan
16 oz
5859500055
Naturally More Peanut Butter, Gluten Free Vegan
26 oz
7989311202
Open Nature Crunchy Peanut Butter
16 oz
7989311201
Open Nature Old Fashioned Creamy Peanut Butter
16 oz
5855200003
Peanut Power Butter, Original Formula
16 oz
5855200007
Peanut Power Butter, Original Formula
4 lb
4792100444
Serious Food Silly Prices Tahini
12 oz
4792100442
Serious Food, Silly Prices Almond Butter Creamy
12 oz
4792100438
Serious Food, Silly Prices Organic No-Stir Peanut Butter, Creamy
16 oz
4792100439
Serious Food, Silly Prices Organic No-Stir Peanut Butter, Crunchy
16 oz
4792100436
Serious Food, Silly Prices Organic Peanut Butter, Creamy
16 oz
4792100434
Serious Food, Silly Prices, No-Stir Peanut Butter, Creamy
16 oz
4792100435
Serious Food, Silly Prices, No-Stir Peanut Butter, Crunchy
16 oz
4792100432
Serious Food, Silly Prices, Peanut Butter, Creamy
16 oz
8506000004
Snaclite Power PB
16 oz
7487500433
Sprout's Creamy Almond Butter
16 oz
7487500336
Sprout's Creamy Peanut Butter
16 oz
7487500431
Sprout's Creamy Peanut Butter
16 oz
7487500434
Sprout's Crunchy Almond Butter
16 oz
7487500337
Sprout's Crunchy Peanut Butter
16 oz
7487500334
Sprouts Farmers Market Creamy Peanut Butter, No Salt
16 oz
7487500335
Sprouts Farmers Market Crunchy Peanut Butter, No Salt
16 oz
072704
Sunland Almond Butter
5 lb
26570 
Sunland Creamy Dark Roast Peanut Butter
500 lb
4868790301
Sunland Creamy Natural Stabilizer Peanut Butter
50 lbs
4868786704
Sunland Creamy No Stir Peanut Butter
5 lb
22704
Sunland Creamy Peanut Butter
5 lb
22725
Sunland Creamy Peanut Butter
40 lb
047730
Sunland Creamy Peanut Butter
30 lbs
4868726909
Sunland Creamy Peanut Butter
18 oz
4868726910
Sunland Creamy Peanut Butter
12 oz
4868786724
Sunland Creamy Peanut Butter
35 lb
4868709915
Sunland Creamy Peanut Butter with Sea Salt
40 oz
87725 
Sunland Crunchy Natural Stabilized Peanut Butter
40 lb
21705
Sunland Crunchy Peanut Butter
40 lb
4868721722
Sunland Crunchy Peanut Butter
15 lb
062725
Sunland Dark Roast Creamy Peanut Butter
40 lb
4868784301
Sunland Extra Stabilized Organic Creamy Peanut Butter
50 lb
4868772906
Sunland Natural Almond Butter, Creamy Roasted Almond
16 oz
4868767909
Sunland Natural Creamy Peanut Butter
18 oz
48687009704
Sunland Natural Creamy Peanut Butter
5 lb
4868757906
Sunland Natural Mixed Nut Butter, Crunchy Almonds and Peanuts
16 oz
4868722906
Sunland Natural Peanut Butter Creamy Salt Free Valencia
16 oz
4868786906
Sunland Natural Peanut Butter Creamy Valencia No Stir
16 oz
4868787906
Sunland Natural Peanut Butter Crunchy Valencia No Stir
16 oz
4868760906
Sunland Natural Peanut Butter, Creamy Banana Spread
16 oz
4868773906
Sunland Natural Peanut Butter, Creamy Chocolate Spread
16 oz
4868761906
Sunland Natural Peanut Butter, Creamy Raspberry Spread
16 oz
4868771906
Sunland Natural Tahini, Creamy Roasted Sesame`
16 oz
4868722715
Sunland Organic Creamy Peanut Butter
40 lb
4868730725
Sunland Organic Creamy Peanut Butter
40 lb
4868732810
Sunland Organic Valencia Peanut Butter, Creamy
12 oz
4868755810
Sunland Organic Valencia Peanut Butter, Creamy Cherry Vanilla
12 oz
4868754810
Sunland Organic Valencia Peanut Butter, Creamy Dark Chocolate
12 oz
4868731810
Sunland Organic Valencia Peanut Butter, Crunchy
12 oz
4868747810
Sunland Organic Valencia Peanut Butter, Crunchy Chipotle Chile
12 oz
41330
Sunland Organic Valencia Roasted and Blanched Peanuts
30 lbs
029725
Sunland Pecan Deluxe Creamy Peanut Butter
40 lb
028725
Sunland Pecan Deluxe Crunchy Peanut Butter
40 lb
4868763326
Sunland Roasted and Blanched Bar Ready Runner Peanuts
30 lbs
4868763325
Sunland Roasted and Blanched Runner Peanuts
30 lbs
4868771725
Sunland Sesame Tahini
40 lbs
4868785920
Sunland Valencia Peanut Sauce
36 oz
41323
Sunland Valencia Roasted Blanched Salted
30 lbs
00940795
Trader Joe's Almond Butter with Roasted Flaxseeds, Crunchy & Salted
16 oz
00971119
Trader Joe's Valencia Creamy Salted Peanut Butter with Sea Salt
16 oz
00989275
Trader Joe's Valencia Peanut Butter with Roasted Flaxseeds, Crunchy and Salted
16 oz
The following companies have informed FDA and the public of related recalls.  Please see the news release links below for product specifics and recall dates:
back to top
What are the Symptoms of Salmonellosis?
Most people infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most people recover without treatment.
However, in some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the blood stream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics.
Who is at Risk? 
Children are the most likely to get salmonellosis. The rate of diagnosed infections in children less than five years old is higher than the rate in all other persons. Young children, the elderly, and those with compromised immune systems are the most likely to have severe infections. It is estimated that approximately 400 persons die each year with acute salmonellosis.
Who Should be Contacted?
Consumers who show any signs of illness from salmonellosis should consult their health care provider. The FDA encourages consumers with questions about food safety to call 1-888-SAFEFOOD or consult the fda.gov website.
Investigation Progression  
September 20, 2012
FDA, the CDC and the state of California briefed Trader Joe’s on the status of the investigation, and the company volunteered to remove the suspected product from their store shelves. Trader Joe’s has also posted a customer advisory on their internet page and initiated a recall.
September 24, 2012
As part of its investigation, FDA contacted Sunland Inc., which makes Trader Joe’s Valencia Creamy Salted Peanut Butter.  On September 23, FDA and CDC briefed Sunland Inc. on the status of the investigation and the company volunteered to recall the almond butter and peanut butter products that were manufactured on the same product line as Trader Joe’s Valencia Creamy Salted Peanut Butter between May 1 and September 24, 2012.
September 25, 2012
FDA inspectors are continuing their investigation at the Sunland Inc. production facility. On the evening of September 24, Sunland Inc. expanded their recall to about 100 products. A list of those products can be found in the company's recall announcement. 
The product information on this web page is from company recall announcements. The recall information has not been verified by the FDA, and the FDA is not responsible for its contents. The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.
For more information:


CORE Network > FDA Investigates Multistate Outbreak of Salmonella Bredeney Infections Possibly Linked to Trader Joe's Valencia Creamy Salted Peanut Butter

Friday, September 28, 2012

Residential Elevators Recalled for Repair by ThyssenKrupp Access Manufacturing Due to Fall Hazard


Name of Product: LEV II®, Volant™ and Rise™ residential elevators
Units: About 670
Manufacturer: ThyssenKrupp Access Manufacturing LLC, of Roanoke, Ill.
Hazard: The elevator�s door can unlock and open at a landing with no elevator car present, exposing the elevator shaft and posing a fall hazard to consumers.
Incidents/Injuries: None reported
Description: This recall involves LEV II, Volant and Rise residential elevators. The elevators were installed in residences with three or more floors. The elevator�s four-digit model number is part of the longer serial number. Model numbers included in this recall are �RLWL� for the LEV II, �RLGL� for the Volant and �RLRC� for the Rise. The model/serial number is printed in the owner�s manual and at the top of the elevator�s controller, which is mounted at the top of the elevator in the hoistway or shaft.
Sold by: Elevator dealers from December 2010 through August 2012 for between $16,000 and $26,000 installed.
Manufactured in: United States
Remedy: Consumers should stop using the elevators immediately if they see an �E3� or �E8� error code displayed on the elevator. Even if there is no �E3� or �E8� error code displayed, contact the firm to arrange for a free software upgrade for the elevator. The firm�s dealers are directly contacting consumers who purchased the recalled elevators.
Consumer Contact: For more information, contact ThyssenKrupp Access Manufacturing LLC at (800) 925-3100 between 7 a.m. and 5 p.m. CT Monday through Friday, email the firm at levplc@tkaccess.com or visit the firm�s website at www.tkaccess.com and click on �Important Recall Notice.�


Picture of recalled Residential Elevator



Residential Elevators Recalled for Repair by ThyssenKrupp Access Manufacturing Due to Fall Hazard

Friday, September 21, 2012

FDA Sets Defective Products’ Alert

MANILA, Philippines — The Food and Drug Administration (FDA) on Friday set guidelines on the transmission of information between FDA and other government agencies relating to rapid alerts on the recall and withdrawal of health products intended for humans and animals, but are defective or are fake.
The FDA said it will have a written procedure in the issuance, receipt and handling of notifications for defective products, batch recalls and other rapid alerts.
It said the rapid alert system will transmit “only those alerts whose urgency and seriousness cannot permit any delay in transmission.”
An assessment will be made to determine the seriousness of the defect, its potential harm to the patient, animals, consumers, operators and the environment.
The FDA has established three classes of classification in the recall of defective health products.
Class I defects are those which are potentially life threatening. Under this, a rapid alert notice will be sent. These include wrong products whose labels and contents are different; correct product but wrong strength; microbial contamination of sterile injectable or ophthalmic product; chemical contamination with serious medical consequences; mix-up of some products with more than one container involved; and wrong active ingredient in a multi-component product with serious medical consequences.
Those that can cause illness or mistreatment and outside the scope of Class I are classified as Class II defects. These defects are mislabeling; missing or incorrect information on the insert or leaflet; microbial contamination of non-injectable, non-ophtalmic sterile product with medical consequences; chemical and physical contamination; mix-up of products in containers; non-compliance with specification; and faulty closure with serious medical consequences.
Class III defects are those that may not pose significant hazard to health and withdrawal of the product is done for a different reason. These include faulty packaging like wrong or missing batch number of expiry date; faulty closure; and contamination like microbial spoilage or dirt.
In addition, the FDA said the rapid alert system may also be used to notify authorities of the recall of products or an embargo on the distribution of products following the suspension or withdrawal of a manufacturing, importation or wholesale authorization.
Under the system, the FDA will issue the alert if the product is first identified in the Philippines. It will lead in the investigation of the defect and issue appropriate alert.
All alerts will be sent via email.
FDA Sets Defective Products’ Alert | The Manila Bulletin Newspaper Online

Tuesday, September 18, 2012

H&M Recalls Children's Water Bottle Due to Choking Hazard, Sold Exclusively at H&M Stores

Name of Product: Children's Water Bottle
Units: About 2,900
Importer: H&M Hennes & Mauritz, New York, N.Y.
Hazard: The water bottle's spout can break off, posing a choking hazard to children.
Incidents/Injuries: H&M has received one report of an incident in England of the water bottle spout breaking off in a child's mouth as the child was drinking from the bottle. No injuries have been reported.
Description: The 16 oz. water bottles are pink plastic with a crackle design or blue plastic. The bottles have flip-top lids in coordinated pink and blue colors. "H&M Sweden" and "www.hm.com" are embossed on the bottom of the bottle. The recalled products were manufactured in June 2012. The water bottle contains the manufacture date in an embossed date clock on the bottom of the bottle. The inner circle on the clock contains the number 12 with an arrow between the two numbers. The arrow points at the number 6 in an outer circle of numbers.
Sold exclusively at: H&M stores with children's departments nationwide from July 2012 through August 2012 for about $5.
Manufactured in: Italy
Remedy: Consumers should immediately stop using the water bottle and return it to H&M for a full refund.
Consumer Contact: For additional information, contact H&M toll-free at (855) 466-7467 or visit the firm's recall page on its website at www.hm.com


Picture of recalled water bottles


H&M Recalls Children's Water Bottle Due to Choking Hazard, Sold Exclusively at H&M Stores

Friday, September 14, 2012

Bluestem Brands Recalls Range Rider Ride-on Toy Cars Due to Fire and Burn Hazards


Name of Product: Range Rider Ride-On Toy Cars
Units: About 4,700
Importer: Bluestem Brands, Inc., of Eden Prairie, Minn., owner of Fingerhut and Gettington
Hazard: The battery can overheat, smoke, melt and catch on fire, posing fire and burn hazards to consumers.
Incidents/Injuries: Bluestem has received nine reports of incidents in which batteries smoked or caught on fire and melted the battery�s connections or scorched the plastic in the ride-on car. No injuries have been reported.
Description: This recall involves battery-powered Range Rider ride-on toy cars with an off-road vehicle body style and plastic tires. The ride-on cars were sold in pink and tan colors. The recalled Range Riders can be identified by their product code and model number. The model number is on the back of the seat of the ride-on toy car. The product code does not appear on the ride-on toy cars, but can be found on the product carton. The recalled models include:
Model #Product CodeProduct
90407BNI374Tan Range Rider
90407GNU640Pink Range Rider
Sold at: Fingerhut catalogs and online at Fingerhut.com and Gettington.com from September 2010 through May 2012 for between $200 and $230.
Manufactured in: China
Remedy: Consumers should immediately stop using the recalled ride-on toy cars and remove the battery and contact Bluestem for a full refund of the purchase price plus reimbursement for shipping and handling. The firm is directly contacting those who purchased the recalled ride-on toy cars.
Consumer Contact: For more information, contact Bluestem toll-free at (866) 931-5417 between 8 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's websites at www.fingerhut.com or www.gettington.com and click on Product Recall.


Picture of recalled Tan Range Rider Ride-on Toy Car    Picture of recalled Pink Range Rider Ride-on Toy Car


Bluestem Brands Recalls Range Rider Ride-on Toy Cars Due to Fire and Burn Hazards