When consumed by humans, Salmonella can cause an infection, salmonellosis. The symptoms of salmonellosis include nausea, vomiting, abdominal cramps, minimal diarrhea, fever, and headache. Certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems, are particularly susceptible to acquiring salmonellosis from such pet food products and may experience more severe symptoms.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The product is packaged in uncoded plastic containers and sold frozen to private consumers nationwide. Once thawed, the pet food has a shelf life of about 1 week. The firm manufactures the pet food by an as-ordered basis. This expansion of the recall affects those orders placed and shipped from June 21 through June 26, 2010 (produced on 6/21/10).

The firm and FDA are investigating this matter to determine the source of this problem, and will take any additional steps necessary to protect the public health.

To date, both the firm and the FDA have received no reports of Salmonella infection relating to this product.

People who are experiencing the symptoms of Salmonella infection after having handled the pet food product should seek medical attention, and report their use of the product and illness to the nearest FDA office.

People should thoroughly wash their hands after handling the pet food – especially those made from raw animal protein such as meat or fish — to help prevent infection. People may risk bacterial infection not only by handling pet foods, but by contact with pets or surfaces exposed to these foods, so it is important that they thoroughly wash their hands with hot water and soap.

Since certain vulnerable populations, such as children, the elderly, and individuals with compromised immune systems, are particularly at risk from exposure they should avoid handling this product.

Consumers with questions should contact the company at (716) 580-3096, Monday -Friday from 10 am – 4 pm EDT.

Posted @ 8:25 p.m.

Concord Foods was notified by its supplier that an ingredient used in these products and produced by Basic Food Flavors Inc is the subject of a voluntary recall due to potential Salmonella contamination.

The product subject to this recall that was distributed nationwide in the United States under the Concord Foods brand in foil pouches and sold in the produce section of the supermarket is:
(Note: The best by date code is embossed on the left edge of the back panel).

Concord Foods Vegetable Dip Seasoning – Homestyle (Best By: 07/27/12).
UPC Code: 041409002066       Net weight 1.5 oz (43 g)

To date no known illnesses have been associated with this product and no other types, varieties or different date codes have been affected by this recall. However, since customer safety is our top priority, Concord Foods has voluntarily recalled this product. Concord Foods is working with Food and Drug Administration to conduct this voluntary recall.

Consumers with products carrying this date code should destroy or return them to the store for a full refund.

Consumers with questions should contact Concord Foods at 1-800-924-5775 (Monday – Friday from 9:00 am-4:30 pm EST).

No illnesses have been reported in connection with these products.

Reser’s is recalling the following items sold to retailers and distributors nationwide:

These products should not be eaten. Customers may return them to the place of purchase for a full refund.

No other Reser’s Fine Foods, Inc. products are affected.

Reser’s is notifying the FDA of this voluntary recall. Consumers with questions may contact Reser’s Fine Foods, Inc. Consumer Hotline between the hours of 8am -5pm PST Monday through Friday at 1-888-230-0062 or see the FDA website at http://www.fda.gov.

“Tortilla Soup Mix” is distributed nationwide via mail order delivery and through independent consultant sales. The recalled lots are S1004812411 and S1004912111, which were sold 2/17/2010 through 3/1/2010. All known purchasers of the 320 packages have been contacted and told to destroy them. A full refund has been offered to every customer and consultant.

“Tortilla Soup Mix” is packaged in clear plastic packages with red and beige labeling. The product was sold individually in a 1.96 oz (55.6 g) pouch, and as part of two kits including the “Let’s Make Dinner Collection (stock #40.1032) or the “$800 pre-select” order for consultants (stock #37.0320).

To date, no known illnesses have been associated with this product.

The “Tortilla Soup Mix” was made using Hydrolyzed Vegetable Protein (HVP), manufactured by Basic Food Flavors, Inc., Las Vegas, Nevada. The HVP had tested positive for Salmonella at its original manufacturing plant Basic Food Flavors, Inc.

This product should be destroyed immediately. Consumers with questions should contact Homemade Gourmet Customer Service Department at 1-888-477-2848 (Monday – Friday 8-5 C.S.T.) for replacement, substitution or refund.

The product is packaged in a 3.5 oz plastic bag labeled with UPC Code 673367487915 and sold through retail stores nationwide. All “Best Before” dates are affected by this recall.

Walong Marketing, Inc. initiated the recall after being notified by the FDA of a consumer complaint involving an allergic reaction related to the consumption of the affected product. Subsequent testing by the FDA indicated the product contains peanuts. No illness or allergic reactions have been reported to Walong Marketing, Inc. to date in connection with this product.

Consumers who have purchase the product are urged to return it to the place of purchase for a full refund.  Consumers with question may contact Walong Marketing, Inc. Monday thorough Friday, 9am to 5pm PST at 714-670-8899 ext. 137.

No illness has been reported. The products were sold at less than 300 retail locations nationwide.

Potentially affected varieties include:

• • Green bean, pear & peas, NET WT. 4.22 OZ. (120g), UPC 8 52697 00127 9;
  • Sweet potato, carrot, apple & cinnamon, NET WT. 4.22 OZ. (120g), UPC 8 52697 00128 6;
  • Spinach, mango & pear, NET WT. 4.22 OZ. (120g), UPC 8 52697 00129 3;
  • Butternut squash & apple, NET WT. 4.22 OZ. (120g), UPC 8 52697 00130 9;
  • Banana, peach, coconut & prunes, NET WT. 4.22 OZ. (120g), UPC 8 52697 00131 6;
  • Banana, peach & mango, NET WT. 4.22 OZ. (120g), UPC 8 52697 00132 3
  • Mango, NET WT. 3.5 OZ. (99g), UPC 8 52697 00134 7
  • Spinach Mango Pear, NET WT. 3.5 OZ. (99g), UPC 8 52697 00139 2
  • Apricot Sweet Potato, NET WT. 3.5 OZ. (99g), UPC 8 52697 00136 1

The above meals are packaged in plastic pouches with plastic caps.

To determine if a specific product is part of this voluntary recall, consumers should examine product packaging for expiration date codes between November 2010 and January 2011. These dates are printed as the first seven characters of a 15-character string, as illustrated in the accompanying illustration.

Less than half of one percent of the products sold to date is affected by this packaging defect; no other products sold by the company are affected. As standard practice for Nurture, all products sold are sent to a laboratory for food safety testing prior to market release and no harmful bacteria have been detected in damaged packages to date.

One consumer complaint was received regarding swollen and leaking pouches, and no illnesses have been reported. The company has worked quickly with the manufacturer to identify the cause of the malfunction and the issue has been resolved.

“We are committed to ensuring our organic foods are not only delicious, convenient, and as healthy as possible, but also delivered in the highest quality, dependable package for our youngest consumers,” says Shazi Visram, Nurture, Inc.’s Founder and CEO. “As a mother-to-be expecting my first child to arrive any day now, I know firsthand how critical it is for parents to have complete confidence in the foods they serve their children. We stand behind our mission to provide only the very best, which is why we have taken the measure to voluntarily recall these products.”

Nurture has worked with the contract manufacturer and the US Food and Drug Administration to resolve the matter.

While no illness has been reported, consumers who have purchased affected products should not consume or serve any swollen or leaky pouches and may return them to their place of purchase for a full refund or contact Nurture Inc directly for a full refund or exchange. Consumers with questions and would like more detailed information are encouraged to contact Nurture, Inc. at 212-374-2779, Monday through Friday from 9:00 a.m. to 5:30 p.m. Eastern time.

The product was distributed nationwide through retail stores and Internet sales.

Although no illnesses associated with these products have been reported, the FDA is advising consumers in possession of these products not to handle or feed them to their pets.

In December 2009, the FDA conducted routine testing of Merrick Beef Filet Squares and detected a positive finding for Salmonella. A follow-up inspection found deficiencies in the packaging and manufacturing processes.

Salmonella can affect both humans and animals. People handling dry pet treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the treats or any surfaces exposed to these products. Consumers should dispose of these products in a safe manner by securing them in a covered trash receptacle.

Healthy people infected with Salmonella may experience some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Although rare, Salmonella can result in more serious ailments including arterial infections, endocarditis (inflammation of the lining of the heart), arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their health care provider immediately.

Pets with Salmonella infections may become lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets may experience only a decreased appetite, fever and abdominal pain. Infected, but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed any of the affected product or is experiencing any of these symptoms, contact your veterinarian immediately.

The affected Merrick Beef Filet Squares were packaged in a 10-ounce green, red and tan re-sealable plastic bag. The “best by” date is imprinted on the top portion of the bag, which is torn off when the bag is opened. The FDA recommends that consumers who are unable to determine the “best by” date discontinue use of the product.

Consumers can report complaints about FDA-regulated pet food and pet treat products by calling the consumer complaint coordinator in their area. Please see http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm for additional information.

Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials. The health effects of this chemical have not been well studied but no serious events have been documented in the medical literature. A small number of the product lots being recalled were associated with the complaints of an unusual moldy, musty, or mildew-like odor, and some of these lots were found to contain trace amounts of TBA. In December 2009, McNeil Consumer Healthcare also recalled all lots of TYLENOL Arthritis Pain 100 count with EZ-OPEN CAP related to this issue. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints.

In addition to the product recall, McNeil Consumer Healthcare is continuing their investigation into this issue and is taking further actions that include ceasing shipment of products produced using materials shipped on these wood pallets and requiring suppliers who ship materials to our plants to discontinue the use of these pallets. We will continue to closely monitor and evaluate the situation and consult with the FDA.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions or information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected product lot numbers for the recalled products can be found on the side of the bottle label.

McNeil Consumer Healthcare Division of McNeil-PPC, Inc. markets a broad range of well-known and trusted over-the-counter (OTC) products.

FULL RECALLED PRODUCT LIST (PDF – 179.38 KB)

No illnesses have been reported to date in connection with this problem.

The recalled products were distributed nationwide in the following retail stores: Hy-Vee, CUB, Rainbow, Byerlys Lunds, Target, Whole Foods, Jewel, Dominicks, Marsh, Price Chopper, Shop rite, Nash Finch, Sam’s Club, Costco, Safeway.

The following recalled products were sold under the Parkers Farm or Parkers label:

~~~16 ounce peanut butter in square plastic containers (tub with snap on lid), varieties are creamy, crunchy, honey creamy and honey crunchy with sell by dates between 11/14/2010 and 12/31/2010**.

~~~34 ounce peanut butter in round plastic containers (tub with snap on lid), varieties are creamy and crunchy with sell by dates between 8/11/2010 and 9/30/2010**.

~~~7 ounce bagel spreads in white plastic containers (tub with snap on lid), varieties are garden veggie, wild berry, strawberry, apple cinnamon and honey walnut) with sell by dates between 5/13/2010 and 6/30/2010**.

~~~14 ounce dips & spreads in square plastic containers (tub with snap on lid), varieties are jalapeño nacho, pimento and salsa con queso with sell by dates between 8/11/2010 and 9/30/2010**.

~~~8 ounce, 12 ounce and 16 ounce cold pack cheese in round or square plastic containers (tub with snap on lid), varieties are sharp cheddar, bacon, onion, smoked cheddar, swiss almond, horseradish, garlic, port wine, and swiss & cheddar with sell by dates between 11/14/2010 and 12/31/2010**.

~~~16 ounce salsa in square plastic containers (tub with snap on lid), varieties are hot, mild, garlic, black bean and fire roasted with sell by dates between 3/14/2010 and 4/30/2010**.

Other labels affected by this recall:

~~~16 ounce Happy Farms Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates between 11/24/2010 and 12/10/2010**.

~~~8 ounce Kroger Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine and swiss almond with sell by dates between 11/18/2010 thru 12/15/2010**

~~~8 ounce Central Markets Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port win and swiss almond, horseradish with sell by dates of 12/9/2010**

~~~14 oz. Central Markets Salsa Con Queso in round plastic containers (tub with snap on lid) with sell by dates of 8/16/2010**.

~~~16 oz. Central Markets Salsa in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish with sell by dates of 3/17/2010 thru 3/24/2010**.

~~~8 oz. Dutch Farms Cold Pack Cheese in round plastic containers (tub with snap on lid), varieties are sharp cheddar, port wine, swiss almond, horseradish, and swiss & cheddar with sell by dates of 11/16/2010 thru 11/18/2010**.

**NOTE:  Sell by dates are clearly printed on container ½ inch from top

Example:       Sell By 10/21/10
07:56

The recall was a result of a sampling done by the state of Wisconsin and the state of Minnesota which revealed that some finished products contained the bacteria. FDA and the company continue their investigation as to what caused the problem. No illnesses have been reported to date in connection with the problem.

Consumers who have purchased these products are urged to return in to the place of purchase for a full refund. Consumers with questions may contact the company at (800)869-6685.

“We are voluntarily recalling the product line from use in the Magnetic Resonance (MR) environment,” Gackowski said. “We are requesting that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. We are in the process of sending labels to our customers to be attached per instructions to remind the hospitals that the product line should not be used in the MR environment.

“In the past, we have stated that the Thermoflect product may be used in the MR environment. However, after being informed by the FDA, at this time we will not promote the products for use in the Magnetic Resonance Environment.  However, the product is still safe and effective for use in treating hypothermia.”

We have been advised by the FDA that a report has been filed of an injury to an (MRI) patient.  Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one.  There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure we are voluntarily recalling the product line for relabeling.

Thermoflect products are distributed nationally and internationally.  A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

We have concluded that there is currently no ASTM International standard to test Thermoflect in the MR environment, although we have conducted multiple laboratory and field tests. “Until an ASTM standard has been developed by ASTM International, we have removed statements on our website and in our product literature that Thermoflect is MR-Conditional or MR-Compatible.

“In addition to issuing this news release to appropriate magazine and trade paper listings, we have sent letters to our customers, hospitals, and doctors in radiology and will follow up with training and verification surveys.”

“At Encompass Group, our mission is always to help healthcare and hospitality providers create safe and comfortable environments for patients, staff, residents and guests. This voluntary recall is another example of our ongoing commitment to those objectives”

For More Information, contact
Jea R. Gackowski, C.H.B., C.C.S.
Corporate Compliance Officer
770-626-2044
Monday – Friday 9 a.m. – 5 p.m. eastern

The uncharacteristic smell is caused by the presence of trace amounts of a chemical called  2,4,6-tribromoanisole.  The source of 2,4,6-tribromoanisole is believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious.

Consumers who purchased TYLENOL  Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.   For these instructions or information regarding how to return or dispose of the product, consumers should call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) or log on to the internet at www.tylenol.com.  Consumers who have medical concerns or questions should contact their healthcare provider.  Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The affected TYLENOL  Arthritis Pain Caplet 100 count product lot numbers can be found on the side of the bottle label. See the full list of affected product lot numbers below:

Recalled Product- Full List (LINK: http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tar_recall.inc

Only the TYLENOL  Arthritis Pain Caplet 100’s with the distinctive red EZ-OPEN CAP are affected by this action.  All other TYLENOL Arthritis Pain products remain commercially available. McNeil Consumer Healthcare will reintroduce the TYLENOL Arthritis Pain Caplet 100 count product by January, 2010 after moving production to a new facility.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. markets a broad range of well-known and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare is most widely recognized for the complete line of TYLENOL  acetaminophen products, the leading pain reliever brand in the adult and pediatric categories.

Consumers who have an allergy or severe sensitivity to milk protein or potatoes run the potential risk of a health problem or illness if they consume these lots of product.

No confirmed illnesses have been reported to date.

The recalled product was distributed to food stores nationwide. The affected product and lot codes are as follows:

The lot code can be found on the bottom of each individual soup can.

Consumers who have purchased any products covered by this recall are urged to return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall please call 1-800-423-4846 (9:00 AM – 7:00 PM Eastern Time).

Posted @ 10:33 p.m.

These products are currently being sold as a dietary supplement throughout the U.S. Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09  contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved drug. The active drug ingredient is not listed on the product label.

The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.  Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Dietary Supplements Sold Under Lot Numbers

**Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.
***If you have a product with a different name but the same lot number please contact Atlas Operations, Inc. for recall instructions.

Our laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil.   Atlas Operations takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.  We take the utmost pride in our products’ quality control without compromising our customer’s health.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase.  You may also return products directly to Atlas Operations.  Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am – 5:00 pm EST for instructions on the return and refund process.

It is the position of Atlas Operations, Inc. that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.  Online:  www.fda.gov/MedWatch/report.htm.  Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm.    Mail to address on the pre-addressed form.  Fax: 1-800-FDA-0178.

Simple Foods, Inc. of Tonawanda, NY is recalling Pre-packaged varieties of Carob Cups, Carob Squares and Carob Rice Cakes, because they may contain undeclared traces of milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Carob Peanut Butter Cups, Carob Almond Butter Cups, Carob Mint Crème Cups, Pre-packaged Carob Brown Rice Crunch, Pre-packaged Carob Peanut Butter Squares, Pre-packaged Crispy Carob Peanut Butter Squares, Pre-Packaged Carob Coated Rice Cakes, Pre-packaged Carob Coated Mint Rice Cakes, and Pre-packaged Carob Almond Butter Coated Rice Cakes were distributed to local retail health food stores and food co-ops in the following states: California, Connecticut, Colorado, Delaware, Florida, Georgia, Indiana, Illinois, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington D.C., and Wisconsin.

Each recalled product can be identified through the UPC Code as well as the individual package weight:

1 ounce Carob Peanut Butter Cups 36664 00200,

1 ounce Carob Almond Butter Cups 36664 0201

1 ounce Carob Mint Crème Cup 36664 0202

1.6 ounce Carob Brown Rice Crunch 36664 00300

1.6 ounce Carob Peanut Butter Squares 36664 00301

1.6 ounce Crispy Carob Peanut Butter Squares 3664 00303

6.5 ounce Carob Coated Rice Cakes 36664 00400

6.5 ounce Carob Mint Coated Rice Cakes 3664 00401

6.5 ounce Carob Almond Butter Coated Rice Cakes 3664 00402.

There has been ONE allergic reaction reported that is waiting to be confirmed as of today’s date.

“The recall was initiated after it was discovered that product containing dairy (traces of milk) was distributed in packaging that did not reveal the presence of dairy (traces of milk). Subsequent investigation indicates the problem was caused by the supplier of carob confectionery coating using machinery that is also used to process materials that may contain milk.”

Consumers with a milk allergy who have purchased Carob Peanut Butter Cups, Carob Almond Butter Cups, Carob Mint Crème Cups, Pre-packaged Carob Brown Rice Crunch, Pre-packaged Carob Peanut Butter Squares, Pre-packaged Crispy Carob Peanut Butter Squares, Pre-Packaged Carob Coated Rice Cakes, Pre-packaged Carob Mint Coated Rice Cakes, and Pre-packaged Carob Almond Butter Coated Rice Cakes may return it to the place of purchase for a full refund. Consumers with questions may contact Simple Foods, Inc. at (716) 743 – 8850.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo)

• Product Name: Alka-Seltzer Plus Day & Night Liquid Gels
• Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
• UPC#: 016500537779
• Lot #: 296939L
• Expiration: 5/11

This product was sold only in the U.S. at retail outlets nationwide.

This recall does not impact any Alka-Seltzer Plus Day & Night Cold Formula Effervescent products, individually packaged Alka-Seltzer Plus Day Non-Drowsy Cold Formula products, individually packaged Alka-Seltzer Plus Night Cold Formula products, or any other lot of Alka-Seltzer Plus Day & Night Cold Formula Liquid-Gels.

The company initiated an investigation following consumer reports and found that in a limited number of combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from a single lot, the information on the underside of the blister package was reversed. Therefore, the label for the green Night product appears under some of the blue Day product and vice versa. As such, there is a risk that consumers may not be aware of the warnings of an antihistamine in the product that could cause drowsiness.

Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall (details below) should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. Consumers should contact our Consumer Relations Call Center at 1(800) 986-3307 (available Monday – Friday 8:30 AM – 5:30PM eastern standard time.) Any consumer with a medical concern or questions should contact their healthcare provider.

About Bayer Consumer Care
The Consumer Care division of Bayer HealthCare, is headquartered in Morristown, New Jersey, USA. Bayer Consumer Care is among the largest marketers of over-the-counter medications and nutritional supplements in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Aspirin, ALEVE, Alka-Seltzer, Midol, One A Day Vitamins, and Flintstones vitamins.

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

All other sizes and varieties of College Inn Chicken Broth are correctly labeled and therefore are not affected by this voluntary recall.

College Inn is voluntarily recalling College Inn No MSG Chicken Broth in individual 14 ½ oz cans due to the presence of wheat (an allergen) which was not declared in the ingredient statement. Also, the label incorrectly states that the product does not contain Monosodium Glutamate (MSG). The following product is subject to the voluntary recall:

People who are allergic to wheat may run a risk of serious adverse health consequences by consuming this product. To date, no illnesses have been reported in connection with this mislabeling.

Individuals without an allergy to wheat and without a sensitivity to Monosodium Glutamate may continue to enjoy this product.

College Inn products are 100% guaranteed. Consumers can visit www.CollegeInn.com, or contact its Consumer Hotline at (800) 552-7684 for further information about the voluntary recall and for instructions on obtaining replacement product. College Inn values the health and well-being of its consumers, and regrets this situation.

About College Inn

College Inn is a subsidiary of Del Monte Foods Company. For more than 80 years College Inn brand has been cooking up quality, great-tasting chicken, beef and vegetable broths and stocks to give consumers that great homemade taste they grew up with.

The College Inn family of products also includes low sodium and organic options. Visit www.CollegeInn.com for more information.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action.  The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product.  These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

This lot number is listed on both the outer carton and the bottle.  Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday – Friday, 9AM – 6PM US ET, Saturday – Sunday, 9AM – 4PM US ET)

From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM – 9PM local time and will continue Monday – Friday, 8AM – 6PM local time, Saturday – Sunday, 9AM – 5PM local time)

Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

The Tasty Dish Snack Tubs weredistributed and sold nationwide to Bed Bath & Beyond retail stores.

The products come in clear plastic packages that have a triangular front label identifying the Brand: Tasty Dish, the Product Name: Chocolate Almonds, Chocolate Raisins, or Sour Neon Worms and the Net Weight: Chocolate Almonds are 9.75 oz. (276g), Chocolate Raisins are 11oz. (311), and Sour Neon Worms are 9.5 oz. (269g) and they all have a 4” clear film safety shrink band on them.  Sku numbers and UPC numbers listed below.

No illnesses have been reported to date in connection with this problem

This voluntary recall was initiated after receiving a report that a small percentage of the tubs in the retail locations were missing the back label.  All of the retails stores have been inspected and any tubs that are missing the back labels have been removed from the shelves.  Subsequent investigation indicates the problem was caused by a temporary breakdown in the packaging process. The labeling machine that applied the back label which contains the ingredient statement, nutritional information and allergen listing experienced a mechanical malfunction that went undetected by the operator.

Consumers who have purchased these Tasty Dish Snack Tubs and find no back label containing the ingredient statement, nutritional information and allergen listing are urged not to consume the product and to return it to Bed Bath & Beyond for a full refund. Consumers with questions may contact Nassau Candy directly at 516-433-7100 ext 297, Monday – Friday 9 am -4 pm ET.

Hospira is undertaking this recall in consideration of the potential for safety issues if the products are administered to patients.  Since these particulate contaminants do not dissolve in blood they could potentially act as emboli and impede blood flow.  Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS).  Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.

Hospira has not received any reports of adverse events related to this issue. Hospira has identified the root cause and corrective actions have been implemented. Hospira has made the U.S. Food and Drug Administration (FDA) aware of the situation.

Anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.

Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Hospira is currently manufacturing both products and has begun to ship replacement product.  Please contact Hospira Customer Care at 1-877-946-7747 for further details.

About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness^™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at www.hospira.com.

The recalled products include only the following types of Dentley’s Beef Hooves purchased between Oct. 2, 2009 and Nov. 3, 2009:

Dentley’s Bulk Cattle Hoof UPC# 73725703323
Dentley’s 10 Pack Beef Hooves UPC# 73725736055

No other products are included in this recall.

The affected products were shipped from the Pet Carousel plant to three PetSmart distribution centers in Ottawa, Ill.; Groveport, Ohio and Newnan, Ga.; and then shipped directly to certain PetSmart stores.  Although the affected product was not shipped to every store, as a precautionary measure PetSmart immediately recalled the product from all of its US stores and instituted a register block to prevent any product from being inadvertently scanned and sold.  In addition, PetSmart removed the product from the PetSmart.com Web site and notified PetPerks customers with valid e-mail addresses in the PetSmart database who purchased the affected products.

Salmonellosis is an infection with bacteria called salmonella. Most persons infected with salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts four to seven days, and most persons recover without treatment. However, in some individuals, 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. The elderly, infants, and those with impaired immune systems are more likely to have a severe illness.

Many dogs do not show clinical signs of salmonella. However, when they do, they often have diarrhea or other signs of systemic infections.

Customers who purchased the recalled products should discontinue use immediately and return the product to any PetSmart store for a complete refund or exchange. Customers who have concerns about their health or their pet’s health should consult a medical professional.  For additional information about the recall, customers can visit www.petsmartfacts.com, www.petsmart.com ; www.fda.govor contact PetSmart Customer Service at 1-888-839-9638.

PetSmart, Inc. is the largest specialty pet retailer of services and solutions for the lifetime needs of pets. The company operates more than 1,145 pet stores in the United States and Canada, 156 in-store PetSmart PetsHotel(R) cat and dog boarding facilities, and is a leading online provider of pet supplies and pet care information (www.petsmart.com). PetSmart provides a broad range of competitively priced pet food and pet products; and offers complete pet training, pet grooming, pet boarding, Doggie Day Camp(SM) pet day care services and pet adoption services. Since 1994, PetSmart Charities, Inc., an independent 501(c)(3) non-profit animal welfare organization, has funded more than $87 million in grants and programs benefiting animal welfare organizations and, through its in-store pet adoption programs, has helped save the lives of more than 3.7 million pets.

FOR MORE INFORMATION:
www.petsmartfacts.com
customercare@petsmart.com
1-888-839-9638

NEWS MEDIA CONTACT:
Jessica White
PetSmart Media Line (623) 587-2177
mediarelations@ssg.petsmart.com

People who have allergies to milk products run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Almond Cookies were distributed to Dean & Deluca for resale as part of their “Americana Cookie” collection.  The product comes in a 6 ounce, clear plastic package sold with 5 other flavors of cookies in a 36 oz. silver tin. The product bears no code or UPC but was distributed to Dean & Deluca in August 2009 for sale in their catalog and online.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not indicate the presence of butter (milk).  Investigation indicates that the problem was caused by a temporary breakdown in the company’s packaging process.  The situation has been rectified by production of a new label with a complete ingredients listing.

Consumers who have purchased the product are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact Charleston Cookie Company at 843-762-4185.  Business hours are Monday through Friday from 8 am to 5 pm.

Caramel Chocolate Truffle Hot Chocolate Mix was distributed domestically through direct delivery, mail order and through retail stores. This product is also shipped to Canada, United Kingdom, Japan and the Netherlands. Product distributed between January 2007 and November 2, 2009 is subject to this recall.

Caramel Chocolate Truffle Hot Chocolate Mix is packaged in a cone shape poly bag with a hanging tag attached to the front of the package and SKU# 3204, UPC 94522 01015 on the back of the label.

No illnesses have been reported to date.

The recall was initiated after it was discovered that product containing tree nuts was distributed in packaging that did not reveal the presence of tree nuts.

Consumers who have purchased Caramel Chocolate Truffle Hot Cocoa Mix manufactured by Pelican Bay LTD are urged to call 1-800-826-8982, 9AM to 5 PM EST for information on product returns and replacement.

]]> http://racinenews.org/2009/11/03/pelican-bay-ltd-issues-nationwide-allergy-alert-on-undeclared-tree-nuts-in-caramel-chocolate-truffle-hot-chocolate-mix/feed/ 0 http://racinenews.org/2009/11/03/bodybuilding-com-is-conducting-a-voluntary-nationwide-and-international-recall-of-65-dietary-supplements-that-may-contain-steroids/ http://racinenews.org/2009/11/03/bodybuilding-com-is-conducting-a-voluntary-nationwide-and-international-recall-of-65-dietary-supplements-that-may-contain-steroids/#comments Tue, 03 Nov 2009 05:00:20 +0000 The Racine News Team http://racinenews.org/?p=35973 Boise, ID – As part of its ongoing cooperation with the Food and Drug Administration (“FDA”), Bodybuilding.com, LLC (the “Company”) announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the “Recalled Products”) described on the attached list, that were sold through the Company’s website, www.bodybuilding.com.

The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” While the Company has not had an opportunity to independently confirm the FDA’s concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.

Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.

The Company has not received to date any reports of adverse events in connection with the Recalled Products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with the FDA to conduct a recall of the products the FDA has identified as containing steroids. Prior to agreeing to carry the Recalled Products, the Company received assurances from all of the manufacturers of the Recalled Products that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient. Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.

Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postagepaid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].

The Company is committed to providing accurate information about its products. The Company is working voluntarily with the FDA in this recall process.

Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.

RECALLED PRODUCT LIST

Brand Name

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge

Ergopharm 6-OXO

Ergopharm 6-OXO Extreme

EST (aka Engineered Sports Technology) MethAnstance

Extreme Labs Susto-Test Depot

Fizogen ON Cycle II Hardcore

G.E.T/ (Genetic Edge Technologies) SUS-500

G.E.T/ (Genetic Edge Technologies) Tren-250

Hardcore Formulations T-Roid

I Force Nutrition 1,4 AD Bold 200

I Force Dymethazine/Reversitol Combo Pack

I Force Reversitol

I Force Nutrition 17a PheraFLEX

I Force Nutrition Dymethazine

I Force Nutrition Methadrol

IDS (aka Innovative Delivery Systems) Bromodrol

IDS (aka Innovative Delivery Systems) Grow Tabs TR

IDS (aka Innovative Delivery Systems) Mass Tabs

IDS (aka Innovative Delivery Systems) Oxodrol Pro

IDS (aka Innovative Delivery Systems) Ripped Tabs TR

IDS (aka Innovative Delivery Systems) Rapid Release

Ripped Tabs

Kilo Sports Massdrol

Kilo Sports Phera-Mass

Kilo Sports Trenadrol

Monster Caps Monster Caps

Myogenix Spawn

Nutra Coastal D-Stianozol

Nutra Coastal H-Drol

Nutra Coastal MDIT

Nutra Coastal S-Drol

Nutra Coastal Trena

Performance Anabolics Methastadrol

Performance Anabolics Tri-Methyl X

Purus Labs E-pol Inslinsified

Purus Labs Nasty Mass

Rage RV2

Rage RV3

Rage RV4

Rage RV5

Redefine Nutrition Finaflex 550-XD

Redefine Nutrition Finaflex Ripped

Transform Supplements Forged Extreme Mass

Transform Supplements Forged Lean Mass

If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Consumers who have any Accusure  Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

The recall is being made with the knowledge of the Food and Drug Administration.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax.

• Online:www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

This voluntary recall is limited to this specific lot number (931AB5YN07) and was distributed only in the United States, and specifically to the following states: AL, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, NC, OH, OR, TX, UT, WA and WI.

Dove Caramel Pecan Perfection is sold in a brown and gold 15.10 fl. oz. pint container and pictures a ribbon of caramel, pecans and a square of Dove® Brand Chocolate on the front.

The voluntary recall was initiated after Dove Caramel Pecan Perfection containing peanuts in lot number 931AB5YN07 was discovered.  Mars Snackfood US was able to quickly confirm that only this lot is affected and, out of an abundance of caution, issued a voluntary recall for potentially affected containers of the ice cream.

Mars Snackfood US will work with retail customers to ensure that the recalled products are not on store shelves. In the event that consumers believe they have purchased products affected by this voluntary recall, they should return the product to the store where they purchased it for a full refund.   Consumers with questions may call our toll-free number: 800-551-0895 between 8:30 AM and 5:00 PM Monday – Friday.

The recalled WHITE LOTUS SEED PASTE MOON CAKE (2 YOLKS) was distributed nationwide in an uncoded, 22.5 oz. metal tin. It is product of China.

The recall was initialed after 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 presence of eggs in packages of WHITE LOTUS SEED PASTE MOON CAKE (2 YOLKS) which did not declare eggs as an ingredient on the label.

No illnesses have been reported to date in connection with this problem.

Consumers who are allergic to eggs and purchased WHITE LOTUS SEED PASTE MOON CAKE (2 YOLKS) are urged to return them to the place of purchase. Consumers with questions may contact the company at 646-388-3032

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial

NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This voluntary recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product. This recall does not include other concentrations of AMERICAN REGENT Ketorolac Tromethamine Injection, USP. American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients, including obstruction of blood vessels which can induce pulmonary emboli or thrombosis, activate platelets and/or neutrophils to induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas, and local irritation at the injection site.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 mg/mL for patient care and should immediately quarantine any product for return.

“Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks,” said Mary Jane Helenek, President and CEO of American Regent.

On Friday, October 16, 2009, American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. This recall does not affect the other strength of Ketorolac Tromethamine Injection, USP, 15mg/mL, 1 mL Single Dose Vial, NDC # 0517-0601-25.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the Agency.

As is standard practice, and as stated in the Ketorolac Tromethamine Injection Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit”

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-9236. Adverse reactions may also be reported to FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-FDA-1088], or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178].

Ketorolac Tromethamine Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

No illnesses have been reported in connection with this product and no other Plum Organics products are affected. As a further precaution, samples from every Plum Organics product manufactured before and after this batch were tested and found to be within quality standards.

The recall was undertaken as a precaution due to the risk of potential contamination with Clostridium botulinum, which can cause botulism, a serious and sometimes lifethreatening condition. Consumers should not use these products, even if they appear to be normal, because of the possible health risk. Symptoms of botulism poisoning in humans include general weakness, dizziness, double-vision and trouble with speaking or swallowing. People experiencing these problems should seek immediate medical attention.

“The product did not meet the FDA guidelines for proper acidity level,” said Dr. Paul Gerhardt, a Food Science Ph.D. and member of the Plum Organics action team. “Though the risk of illness from this one batch is minimal, Plum Organics is taking the extraordinary step of recalling all Apple & Carrot Baby Food Pouches with best by date May 21, 2010.”

“As a mother, the safety and satisfaction of our customers and their children is my highest concern,” said Plum Organics Founder Gigi Lee Chang. Due to a mixing error during production, one batch of this product was improperly blended. As a result, it did not meet our company’s standard for quality. We are taking the extra step of recalling all Apple & Carrot Portable Pouches with this date to eliminate any question in the minds of consumers about the safety of our products. Plum Organics was founded on the vision of superior quality and nutritious baby food; we are committed to these values and our consumers.”

Consumers who have purchased the Plum Organics Apple & Carrot pouch-based baby food with a best by date May 21, 2010 and with the UPC # 890180001221 can return the product for a full refund at any Toys-R-Us or Babies-R-Us store.

The recall is being undertaken with the knowledge of the U.S. Food & Drug Administration.

Consumers with any questions are asked to call 888-974-3555 between the hours of 8 am – 5 pm PST, or email info@plumorganics.com.

Plum Organics is the leading premium organic baby food brand in the nation.

The recall applies only to the “Limited Edition – Classic Candy Flavors” two-pack caramel apple, UPC code of 34986-13000 with a “Best By” date on or before 10/15/09. The product is in a clear plastic package with a dark brown label. No other Affy Tapple® products are affected by this alert. The product has been distributed to select stores in Illinois, Michigan, Indiana, Wisconsin, Ohio and Kentucky.

The Company has not received any reports of illness or allergic reactions but has received a report of a peanut fragment on the topping of one apple and has issued this recall as a precautionary measure. Consumers who are not allergic to peanuts or tree nuts face no safety risk.

Consumers who have purchased “Limited Edition – Classic Candy Flavors” two-pack caramel apple with the UPC code of 34986-13000 and a “Best By” date on or before 10/15/09 may return it to the point of purchase for a refund. Consumers with questions may contact Affy Tapple at 847-929-6534 between the hours of 8 a.m. and 5 p.m. Central Daylight Time, Monday through Friday.

Neocate  is a hypoallergenic dry powder formula packaged in 14 oz. cans distributed to pharmacies, health care professionals and consumers nationwide. Neocate is not intended for general use and is usually given to infants in the care of health care professionals. The affected cans were distributed in commerce between September 1, 2009 and September 11, 2009.

Nutricia has been informed by the manufacturer of Neocate that, due to a one-time blending error, a limited quantity of the individual cans of Neocate Infant (original formula) contain protein levels lower than that declared on the label.

This limited formulation concern does not present any immediate risks of injury or other adverse health consequences. No adverse events have been reported as a result of this issue. The affected product from Lot # P91877 has a reduced protein level equivalent to 1.75g protein/100kcal – a shortfall of approximately 0.05g protein/100kcal based on the U.S. infant formula minimum requirement of 1.8g protein/100kcal. However, the affected product from Lot # P91877 continues to meet the minimum guidelines for protein established by the World Health Organization.

Although short-term consumption of product from the affected batch is very unlikely to cause immediate nutritional issues, longer term consumption might influence the healthy growth curve in certain infants.

Because the quality and safety of Nutricia’s products and the well-being of its customers are the company’s primary concerns, the voluntary recall has been initiated. The Food and Drug Administration has been apprised of this recall. The company apologizes for any inconvenience to our customers and consumers.

Recommended Action to be Taken by the User

The affected products have the Lot # P91877; this number can be found at the bottom of each can and on the right hand side of the case label.

Parents, caregivers, and health care professionals who have questions or concerns related to the consumption of the affected product are advised to contact the Nutricia North America Customer Helpline at 1-800-365-7354, option 8-6061. We can be reached during normal business hours Monday through Friday from 8:30am EDT to 5:00pm EDT.and for special extended hours 8:30 am EDT to 8:00 pm EDT on Monday and Tuesday, September 28 and 29th.

Working with Nutricia, the manufacturer of Neocate has implemented appropriate corrective and preventative actions, to ensure that this blending error in the manufacture of the product is not repeated. Nutricia will continue to carefully monitor the situation and follow-up with its customers to ensure prompt replacement of the affected product.

For more information please visit www.nutricia-na.com or www.neocate.com.

For further information regarding this release, please contact Meredith Klein, Edelman PR at (312) 233-1236.

Posted @ 9:45 p.m.