Category Archives: Food and Drug Administration

FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall

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Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company’s recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

Medtronic began notifying clinicians outside of the United States in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017.

The updated controller includes enhancements designed to address the potential safety issues identified in the previously communicated notices, including:

  • strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins;
  • functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and
  • redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids.

In addition, the updated controller introduces upgraded internal circuitry designed to improve overall device reliability.

In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors.

With the introduction of the updated controller, Medtronic has begun to remove current HVAD Controllers (product codes 1400,1401US and 1407US) in select geographies, including the U.S. Medtronic also has begun to remove the related adapters (product code 1435), Instructions for Use, Patient Manuals and Emergency Responder Guides.

As part of these activities, Medtronic has provided the following recommendations to physicians:

  • Before the updated controller will be distributed to hospitals, clinicians must complete required training on the updated controller and updated product labeling, including the Instructions for Use and Patient Manual.
  • Following training and the receipt of the updated controllers in hospital inventory, clinicians are requested to quarantine and replace patients’ primary and backup HVAD Controllers and DC adapters under clinical supervision and at a hospital where patient support equipment is available.
  • While Medtronic recommends that HVAD Controllers be exchanged, clinicians should weigh the benefits of the updated controller against the risks of a controller exchange procedure.
  • When clinicians determine a controller exchange is appropriate, they will notify patients who should promptly schedule a controller exchange as soon as the updated controllers are available.
  • Trained hospital staff must educate patients on using the updated controller.

Patients with questions about this announcement should contact their physicians or ventricular assist device (VAD) coordinator at their hospital center.

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

For information or to report a problem, please contact the 24-hour Clinical Support line at +1-888-494-6365 or email FSCA@medtronic.com.

Frito-Lay Recalls Jalapeño Flavored Lay’s Kettle Cooked Potato Chips and Jalapeño Flavored Miss Vickie’s Kettle Cooked Potato Chips

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Frito-Lay announced it is voluntarily recalling select Jalapeño Flavored Lay’s Kettle Cooked potato chips and Jalapeño Flavored Miss Vickie’s Kettle Cooked potato chips due to the potential presence of Salmonella in the seasoning. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

This action is the direct result of a supplier’s recent recall of a seasoning blend which includes jalapeño powder that could contain Salmonella. Although no Salmonella was found in the seasoning supplied to Frito-Lay, the company has decided to recall these products out of an abundance of caution.

No illness related to this matter has been confirmed to date.

The products covered by this recall were distributed in retail stores and via foodservice, vending and other channels throughout the U.S.

The specific recalled product information is listed below:

  • All sizes of the following two products that have a “guaranteed fresh” date of JUL 4 or prior printed on the front upper panel of the package:
    • Jalapeño Flavored Lay’s Kettle Cooked potato chips
    • Jalapeño Flavored Miss Vickie’s Kettle Cooked potato chips
  • All of the following multipack offerings that have a “use by” date of JUN 20 or prior printed on the multipack package. In addition, a “guaranteed fresh” date of JUL 4 or prior is printed on the front upper panel of the individual recalled product packages inside each multipack offering. Any other products or flavors contained in these multipacks are not being recalled.
    • 12 count Lay’s Kettle Cooked Multipack Sack
    • 20 count Frito-Lay Bold Mix Sack
    • 30 count Miss Vickie’s Multipack Tray
    • 30 count Lay’s Kettle Cooked Multipack Tray
    • 32 count Miss Vickie’s Multipack Box

No other flavors of Lay’s Kettle Cooked potato chips or Miss Vickie’s potato chips are impacted or being recalled. Jalapeño Cheddar Flavored Lay’s Kettle Cooked 40% Less Fat potato chips are not impacted or being recalled.

Consumers who have purchased these recalled products are advised not to consume them. Frito-Lay is working with the FDA on this recall to ensure the recalled products are removed from store shelves and are no longer distributed.

Consumers can contact Frito-Lay Consumer Relations at 866-272-9393 for additional information from 9 a.m. to 6 p.m. EST. Representative product images can be found at fritolay.com. For product reimbursement, consumers can visit www.jalapenochiprecall.com.

Campbell Soup Company Recalls Chicken Soup Products Due to Misbranding and Undeclared Allergens

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Class I recall is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health

Campbell Soup Company, a Maxton, N.C. establishment, is recalling approximately 4,185 pounds of chicken soup products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen, which is not declared on the product label. The chicken with whole grain pasta soup items were produced on Feb. 13, 2017.

18.6-oz. cans of “Campbell’s Homestyle Healthy Request Chicken with Whole Grain Pasta” with Best By date of Feb. 13, 2019 located on the bottom of the cans.

The products subject to recall bear establishment number “EST. 4R” on the bottom of the cans. These items were shipped to retail locations in Florida.

The problem was discovered on April 20, 2017 when the firm received notification from their corporate office of multiple consumer complaints of the wrong product noticed inside the cans. The products were labeled as “Campbell’s Homestyle Healthy Request Chicken with Whole Grain Pasta” but actually contain “Campbell’s Homestyle Healthy Request Italian-Style Wedding Spinach & Meatballs in Chicken Broth” soup.

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.

Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts

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DUBLIN – Medtronic plc today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.

Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy.

  • If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
  • Patients and their caregivers should monitor the patient’s condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

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, by regular mail, or by fax.

Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express

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Orlando, Fla. – Fresh Express is announcing a precautionary recall of a limited number of cases of Organic Marketside Spring Mix.

The item subject to the recall is 5 oz. Organic Marketside Spring Mix marketed in a clear container with production code G089B19 and best-if-used-by date of APR 14, 2017 located on the front label, and UPC code 6 8113132897 5 located on the bottom of the container. The recalled salads were distributed only to Walmart stores located in the Southeastern region of the United States.

The recall was necessitated when Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad. Out of an abundance of caution, all salads manufactured in the same production run are being recalled.

No other Marketside salads are included in the recall. Fresh Express salads are not subject to a recall.

Walmart acted quickly to remove the product from store shelves.

Consumers who may have already purchased the recalled product should discard and not consume it. A full refund is available where purchased or by calling the Fresh Express Consumer Response Center toll-free at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Time.

Upon receiving notification, both Walmart and Fresh Express food safety and rapid response teams, in close coordination with regulatory authorities, acted immediately to review all relevant records, launch an intensive investigation and initiate product removal and recall procedures.

Fresh Express takes matters of food safety very seriously and rigorously complies with all food safety regulations including the proscribed Good Agricultural Practices. In addition, a range of stringent controls are in place during growing and harvesting to mitigate against field material from entering the raw product system. In manufacturing, additional controls including thorough washing and filtration systems as well as visual inspections that are designed to eliminate unwanted debris.

Recalled Product Details

  • Organic Marketside Spring Mix – 5 oz. clear container
  • Production Code of G089B19 and best-if-used-by date of APR 14 2017, located on the top label
  • UPC Code of 6 8113132897 5 located on the bottom of the container next to the bar code

Recalled Product Distribution

Fresh Express Precautionary Recall, 5 oz. Organic Marketside Spring Mix
(No other Marketside Salads and No Fresh Express Salads are included in this recall)

Brand PRODUCT NAME SIZE UPC PRODUCTION CODE BEST IF USED BY DATE POSSIBLE DISTRIBUTION STATES
Marketside Organic Spring Mix 5 oz. 6 8113132897 5 G089B19 APR 14 2017 AL, FL, GA, LA, MS, NC, SC, VA,

 

Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector

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Mylan N.V. today announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

U.S. Impacted Lots:

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM087 October 2017

Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.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 either online, by regular mail or by fax.

This voluntary recall is being conducted with the knowledge of FDA.

Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.

More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.

Please see the full Prescribing Information and Patient Information.

Conagra Brands Recalls Hunt’s Chili Kits

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Conagra Brands, Inc., announced today it is voluntarily recalling a limited amount of Hunt’s Chili Kits due to the potential presence of Salmonella in the chili seasoning packet contained in the kit. The chili seasoning used in the packet originated from a supplier who informed the company of the potential presence of Salmonella in a raw material used in the chili seasoning. Although no Salmonella was found in the finished product supplied to Conagra Brands, the company has decided out of an abundance of caution to recall the product.

There have been no reports of adverse reactions or injuries due to consumption of this product to date. Salmonella is a bacterium that can cause diarrhea, fever and abdominal cramps. Most individuals recover without treatment. In some cases, diarrhea may be so severe that the patient needs to be hospitalized. The elderly, infants and those with impaired immune systems are more likely to have a severe illness.

The product covered by this recall was distributed in retail stores, military commissaries and online nationwide in the U.S.; the specific product information is listed below. The product code information is stated on the bottom of the kit below the barcode. No other Hunt’s products or Conagra Brands’ products are impacted by this recall.

Item Description UPC MFG/Lot Code Best By Date
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619500 Apr 04, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534622200 May 01, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619600 Apr 05, 2018

Consumers who have purchased this item are advised not to consume it and return it to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Affairs hotline at 1-800-921-7404, open 9 am through 5 pm CDT, Monday through Friday.

Pro Sports Club Recalls Yogurt Peanut Crunch Bar Because of Possible Health Risk

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Pro Sports Club of Bellevue, WA is recalling 36,957 Yogurt Peanut Crunch bars because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

The Yogurt Peanut Crunch Bar was sold directly to clients at the PRO Sports facilities in Washington (Bellevue, Redmond and Seattle cities) between August 8, 2016 and March 10, 2017. Product was also sold to internet customers through www.2020lifestyles.com.

This recalled Yogurt Peanut Crunch Bars has a brand name 20/20 Life Styles, lot code B.B. 22JUL17 (means best by July 22, 2017), net weight 2 oz., UPC Code 78571 00052.

No illnesses related to the consumption of the Yogurt Peanut Crunch Bars have been reported to date.

The recall was initiated after our manufacturer notified us that the ingredient used in the Yogurt Peanut Crunch Bars was recalled by supplier Soy Nut Butter Company of Glenview, Illinois because it was found to contain E. Coli O157:H7.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Consumers who have purchased Yogurt Peanut Crunch Bars are urged not to consume and to return any remaining product to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-425-895-6533 Monday through Friday, 9AM-5PM PST.

Lakes Farm Raised Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration

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WASHINGTON – Lakes Farm Raised Catfish Inc., a Dundee, Miss. establishment, is recalling approximately 1,695 pounds of siluriformes fish (catfish) products that may be adulterated with residues of public health concern, specifically Malachite Green and Leucomalachite Green, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The siluriformes (catfish) products were produced on March 14 through 17, 2017. The following products are subject to recall: [View Labels (PDF Only)]

  • 15-lb. cardboard boxes of frozen raw “catfish” fillets identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw “catfish” nuggets identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw “catfish” steaks identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw whole “catfish” identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.

The products subject to recall bear establishment number “EST. 48150” inside the USDA mark of inspection. These items were shipped to institutional and retail locations in Mississippi and Tennessee.

The problem was discovered on March 23, 2017, after routine FSIS sampling results revealed violative levels of the chemicals Malachite Green and Leucomalachite Green in the products.

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.

Consumers and media with questions about the recall can contact Earl Lake, President, at (662) 363-1847.

Nutiva Expanded Voluntary Recall In All Lots of Organic Plant Based Protein Superfood 30 Shake

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Nutiva, an Organic Superfoods company, has decided to expand its initial voluntary product recall of the Organic Plant Based Protein Superfood 30 Shake – Vanilla to include all lots of both Vanilla and Chocolate flavored products after identifying that this product may contain trace amounts peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. “We are choosing to voluntarily recall all of our Organic Plant Based Protein Superfood 30 Shakes as a precautionary measure to provide the safest products for our customers,” states John W. Roulac, Nutiva’s CEO.

The affected products include:

Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP101 Organic Plant Based Protein
Superfood 30 Shake –Chocolate		 10 – 1.2 OZ (34g) Packets 6-92752-10713-9
6-92752-10714-6		 6-92752-10715-3 24MAY2016 – 11NOV2016 24 MAY 2018 – 11 NOV 2018
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP105 Organic Plant Based Protein
Superfood 30 Shake -Chocolate		 21.6 OZ
HDPE Jar		 6-92752-10709-2 6-92752-10710-8 03MAY2016 – 11JAN2017 03 MAY 2018 – 11 JAN 2019
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP201 Organic Plant Based Protein
Superfood 30 Shake -Vanilla		 10 – 1.2 OZ (34g) Packets 6-92752-10716-0
6-92752-10717-7		 6-92752-10718-4 06MAY2016– 10NOV2016 06 MAY 2018 – 10 NOV 2018
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP205 Organic Plant Based Protein
Superfood 30 Shake -Vanilla		 21.6 OZ
HDPE Jar		 6-92752-10711-5 6-92752-10712-2 03MAY2016 – 02MAR2017 03 MAY 2018 – 02 MAR 2019

These items were sold on the internet and through distributors in Alabama, California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Nevada, New Hampshire, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.

Consumers who have purchased these items and have an allergy or severe sensitivity to peanuts are urged to not eat the product, and to dispose of it or return it for refund to where it was originally purchased. Nutiva has taken these steps strictly as a precautionary measure to assure our customers of our commitment to quality. No other Nutiva items are impacted by this recall.

Customers with questions may contact (800) 993-4367 between the hours of 8:00 a.m. – 3:00 p.m., Monday – Friday, or email help@nutiva.com.