Category Archives: Food and Drug Administration

The Popcorn Shoppe Issues Allergy Alert on three products

Posted on by

The Popcorn Shoppe in Tiffin, Ohio is voluntarily recalling its Olde Tyme Recipe Popcorn Balls, Edwards Orchard Popcorn Balls and Edwards Orchard West Popcorn Balls (4 individually wrapped 5oz. popcorn balls in a clear plastic bag) due to an undeclared milk and soy allergen. This recall has been initiated due to the ingredient label not stating the milk and soy allergen. People who have an allergy or severe sensitivity to milk and soy run the risk of a serious or life-threatening allergic reaction if they consume this product. Individuals exhibiting signs or symptoms of food bourne illness or allergies should contact a physician immediately.

Products were available for sale at retail locations in Illinois and Ohio. An Ohio Department of Agriculture inspector discovered the mislabeling issue during a routine visit. There have been no reports of illness to date involving products addressed in this recall.

Customers with a milk and/or soy allergies or sensitivity who have purchased the affected product should dispose of it or return it to The Popcorn Shoppe for a replacement. Consumers with questions regarding this recall can contact Melissa Molyet at (567) 207-5432 Monday – Friday 9:00 am. – 5:00 pm. EST.ucm529506ucm529507ucm529510

Nutrisystem Retail Division Voluntarily Recalls One Product Containing Chocolate Cookie Dough Pieces

Posted on by

nutrisystem-1Fort Washington, PA – Nutrisystem Everyday, LLC, the retail division of Nutrisystem, Inc., is voluntarily recalling the Nutricrush Chocolate Chip Cookie Dough bar, manufactured by Noble Foods, Inc. This bar contains a chocolate chip cookie dough ingredient supplied by a third party supplier, which advised that its ingredient might potentially contain Listeria monocytogenes.

The product had very limited distribution of 1 lot/455 cases to ShopRite and Hannaford stores in Connecticut, Delaware, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Virginia, Vermont, and online through Amazon.com and Walmart.com. No other code dates of this product or other Nutrisystem® products in retail are affected. No Nutrisystem ‘direct to consumer’ product is impacted in any way.

Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

This voluntary recall covers the Nutrisystem Nutricrush Chocolate Chip Cookie Dough Bar. The bar was sold as a 5-count carton. The product can be identified by the UPC 6 32674 85579 4, Enjoy by Aug 22 2017 and Lot Code NF082216A. All code information is found on the back panel of the carton.

Nutrisystem is initiating this recall out of an abundance of caution. This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA). Consumers should not eat the recalled product. Consumers may discard the product or return it to the ShopRite or Hannaford from where it was purchased for a full refund. Twenty-four customers of Amazon.com and Walmart.com have already been identified, instructed to discard the product, and will be issued a refund. No illnesses have been reported.

We continue to work closely with regulatory agencies, and remain committed to ensuring we are providing safe products for our consumers to enjoy. Consumers seeking information may call toll-free 1-866-293-8118, Monday through Friday, 7:00 a.m. to 12:00 a.m., and 8:30 a.m. to 5:00 p.m. on Saturdays and Sundays, Eastern Daylight Time.

Members of the news media requiring more information should contact Robin McConnell Shallow at 215-346-8068 or via email at rshallow@nutrisystem.com.

Nestlé USA Initiates Voluntary Recall Of Nestlé® Drumstick® Club 16 Count Variety and 24 Count Vanilla Pack

Posted on by

ucm524635Glendale, CA — Nestlé USA, Inc. is initiating a voluntary recall of its Nestlé Drumstick Club 16 count Variety Pack and 24 count Vanilla Pack (with cones marked for easy individual sale) due to a possible health risk. The two pack sizes contain 4.6 fl.oz. cones and were manufactured in Bakersfield, Calif. and distributed nationally. No other production codes, sizes or varieties of Nestlé Drumstick products are affected by this recall.

The company received positive test results for Listeria monocytogenes (LM) from equipment contact surfaces from a location on the production line where these products are made. There have been no positive test results for LM present in the Drumstick cones themselves. The products impacted by the voluntary recall were put into distribution inadvertently. No illnesses have been reported to date; the company is initiating this recall as a precautionary action to avoid any potential for consumer illness.

Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The Nestlé recall is limited to the Drumstick Club 16 Count Variety Pack and 24 count Vanilla Pack, made at the company’s Bakersfield, Calif. ice cream production facility. The product identification codes can be found on the back of the packages and on the individually marked vanilla cones from the 24 count pack. The two packs being recalled carry distinct UPC codes, as well as a “best before” date and production code.

Description

Production Code

UPC

Best Before Date

DSTK Club CP 16×4.6floz US

 6244580212 72554-11096

Between June 2 – June 15, 2017
6245580212
6246580212
6247580212
6248580212
6249580212
6250580212
6251580212
6252580212
6253580212
6254580212
6255580212
6256580212
6257580212

DSTK Vanilla 24×4.6floz US

 6258580212

72554-00160

Between June 16 – June 19, 2017
6259580212
6260580212
6261580212

Consumers who may have purchased the product listed above should not consume it, but instead should return it to the place of purchase or contact Nestlé Consumer Services for replacement. Please call or text 1-800-681-1676 or email Nestleproductinquiry@casupport.com; representatives are available 24/7. News about this recall also can be found on Nestléusa.com and Drumstick.com.

The quality and safety of Nestlé products remain our number one priority. We apologize for any inconvenience this action represents for both our consumers and retail customers.

Blue Bunny Hoppin’ Hollidoodle Ice Cream Voluntary Recall

Posted on by

bluebunny524818Le Mars, Iowa — Wells Enterprises, Inc. is voluntarily recalling two lots of Blue Bunny Hoppin’ Holidoodle ice cream sold at retail outlets, because they contain snickerdoodle cookie dough pieces recalled by the supplier, Aspen Hills, due to potential contamination with Listeria monocytogenes. Wells has received no reports of illness attributable to this product.

Only Hoppin’ Holidoodle ice cream with the following lot numbers and best if used by dates are included in this recall. The recalled product is a seasonal holiday flavor with very limited geographic distribution in six states. Consumers should check the side of their ice cream packages to check for the following lot numbers and best if used by dates:

Product Name Size UPC, Lot #, Best Used by Date States Distributed
Blue Bunny Hoppin’
Holidoodle
Ice Cream		 46 fluid ounces  UPC 070640014644
LOT 60001 MM 19115 6228
BEST IF USED BY 02/13/18
UPC 070640014651
(High altitude)
LOT 60001 MM 19115 6229
BEST IF USED BY 02/14/18		 NE, OK, KS, MO, AZ,TX

No other Blue Bunny product is included in this recall.

Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

Consumers with product matching lot numbers and best if used by dates should return the products to the retail outlets where purchased for a full refund. Anyone requiring more information should telephone Wells Enterprises, Inc. consumer affairs at 1-800-331-0830.

Mars Petcare US Announces Voluntary Recall of Limited Number of CESAR® Classics Filet Mignon Flavor Wet Dog Food

Posted on by

caeser524703Franklin, Tennessee — Today, Mars Petcare US announced a voluntary recall of a limited number of CESAR® Classics Filet Mignon Flavor product due to a potential choking risk from hard white pieces of plastic which entered the food during the production process. CESAR® Classics Filet Mignon can be purchased individually, as well as, in flavor variety multipacks. The Lot Codes listed below are the only affected products. All other CESAR® products can be safely consumed.

We encourage consumers who have purchased affected product to discard the food or return it to the retailer for a full refund or exchange. While a small number of consumers have reported finding the plastic pieces, to date, we have not received any reports of injury or illness associated with the affected product. The lot codes indicated below should not be sold or consumed.

Affected product was distributed to retail customers throughout the United States. Mars Petcare US is working with all of our distributors and retailers to ensure that the recalled products are no longer sold and are removed from inventory.

Recalled Pet Food

Two lot codes of CESAR® Classics Filet Mignon Flavor wet dog food with the production codes shown below are included in this voluntary recall. Each product will have a lot code printed on side of the tray that begins with 631FKKC, 631GKKC. A Best Before date 080418 (August 4, 2018) and 080518 (August 5, 2018).

The CESAR® Classics Filet Mignon Flavor can be found in variety packs with the following lot codes:

632D14JC, 633B24JC, 634A14JC, 634A24JC, 634B14JC, 634B24JC, 634E14JC, 635A24JC, 635B14JC, 636D24JC, 636E14JC

At Mars Petcare US, we take our responsibility to pets and their owners seriously. Pet owners who have questions about the recall should call 800-421-6456 between the hours of Saturday, October 8, 8:00 am to 12:00 pm CST and Monday through Friday 8:00 am to 4:30 pm CST or visit https://www.cesar.com/notice.

Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters

Posted on by

On September 16, 2016, Vascular Solutions, Inc., initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.

Healthcare facilities that have the affected Twin-Pass dual access catheters should remove the products from their inventory and return them to Vascular Solutions.

The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.

The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 15,896 devices have been manufactured, with 5,784 distributed in the United States and currently unexpired. The condition that led to the recall may affect approximately 9.2% of recalled devices.

Vascular Solutions, Inc. voluntarily initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program Online at http://www.fda.gov/medwatch/report.htm (form available to fax (1-800-FDA-0178) or mail), or you may call the FDA at 1-800-FDA-1088 to request a reporting form.

Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers

Posted on by

lunch-1WASHINGTON D.C. — Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat and soy, known allergens, which are not declared on the product label.

The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:

3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.

The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
lunch-2
lunch-3
The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.

The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

There have been no confirmed reports of adverse reactions due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased this product are urged not to consume it. This product should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact the Kraft Heinz Consumer Relations Center, at 1-800-573-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.com.

Tyson Foods Inc. Recalls Chicken Nugget Products

Posted on by

WASHINGTON — Tyson Foods Inc., a Sedalia, Mo. establishment, is recalling approximately 132,520 pounds of fully cooked chicken nugget products that may be contaminated with hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

This is a Class I Recall which represents a health hazard where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

The fully cooked Panko Chicken Nuggets items were produced on July 18, 2016. The following products are subject to recall:
tyson-1

  • 5-lb. bag containing “Tyson FULLY COOKED PANKO CHICKEN NUGGETS” with a “Best If Used By” date of July 18, 2017 and case code 2006SDL03 and 2006SDL33.
  • 20-lb. bulk packages containing “SPARE TIME Fully Cooked, Panko Chicken Nuggets, Nugget Shaped Chicken Breast Pattie Fritters With Rib Meat” with a production date of July 18, 2016 and case code 2006SDL03.

tyson-2
The products subject to recall bear establishment number “EST. 13556” printed adjacent to the “Best If Used By” date on the back of the package. The 20-pound cases were shipped for institutional use in Pennsylvania and the five-pound bags were shipped to retail locations nationally.

The problem was discovered after the firm received consumer complaints regarding foreign material contamination of chicken nugget products. According to Tyson Foods, the plastic material ranged in size from 21mm in length and 6.5mm in diameter and may have come from a round, hard plastic rod used to connect a plastic transfer belt. The firm said the products pass through a metal detector, but the plastic is not detectable to this technology.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Honeywell recalls one lot of Eyesaline Eyewash Solution

Posted on by

In cooperation with the U.S. Food and Drug Administration (FDA), Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.

Although no injuries have been reported and we have not found any contamination in our batch testing, the voluntary recall is a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.

Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.

All of Honeywell’s distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. See instructions below on how to find the lot number to determine if your supply is covered by this voluntary recall.

Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement.  Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.
ucm517444ucm517445
The affected product and lot number can be identified as follows:

  • Product: 32 ounce Eyesaline Eyewash
  • Lot number:  F16091-61 (no other lot number is subject to recall)
  • The lot number can be found on the outside of the product case, shown at left, and on individual bottles, as shown on the right below.

Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at 1-800-430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

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

ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination

Posted on by

ConAgra-3 ConAgra Foods, a Russellville, Ark. establishment, is recalling approximately 3,806 pounds of frozen chicken and beef entrée products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The metal fragments range in size between 2 and 9 millimeters (mm) in diameter, and are curled, malleable and shiny. The metal fragments may be embedded in the sauce contained within the frozen entrée products.

The frozen chicken and beef entrée items were produced on June 13, 2016 and June 22, 2016. The following products are subject to recall: [View Labels (PDF only)]

* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Signature Spicy Chicken.” with “Use By” date of 6/08/17 and case code 5006616500.
* 22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Brand Mongolian Style Beef.” with “Use By” date of 6/17/17 and case code 5006617400.

The products subject to recall bear establishment number “EST. 233” or “EST. P-115” inside the USDA mark of inspection. These items were shipped to distributors and retail locations in Arkansas, Illinois, Michigan, Minnesota, New York, Vermont, and Wisconsin.

The problem was discovered July 1, 2016, when an establishment employee observed metal fragments while dispensing sugar from a supplier for sauce formulation during processing. The resulting sauce is a component in the frozen entrée products.

There have been no confirmed reports of adverse reactions or injuries due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.