North Country Smokehouse Recalls Pork Sausage Products Due to Misbranding

Class II Recall 028-2019
Health Risk: Low Mar 12, 2019

Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
Press@fsis.usda.gov

 

EDITOR’S NOTE: This release is being updated to include additional information including updated poundage, production dates and corrected use by dates.

WASHINGTON, March 12, 2019 – North Country Smokehouse, a Claremont, N.H. establishment, is recalling approximately 9,000 pounds of pork sausage products due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product has a gluten free claim represented on the front of the label; however, the product contains gluten in the form of wheat. Wheat, which is an allergen, is also listed in the product’s list of ingredients.

The ready-to-eat pork banger sausage items were produced from Jan. 28, 2019 through Feb. 25, 2019. The following products are subject to recall: [View Labels (PDF only)]

  • 12-oz. vacuum-sealed packages containing 4 pieces of “NORTH COUNTRY SMOKEHOUSE NATURAL IRISH BRAND BANGER SAUSAGE” and use by dates from 3/30/19 through 4/30/2019, represented on the packaging.

The products subject to recall bear establishment number “EST. 5390A” inside the USDA mark of inspection. These items were shipped to distribution and retail locations nationwide.

The problem was discovered on March 11, 2019 when the firm notified FSIS that they received a consumer complaint.

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. (more…)

Choice Canning Company, Inc. Recalls Chicken Fried Rice Products Due to Misbranding and Undeclared Allergens

Class I Recall 026-2019
Health Risk: High Mar 11, 2019

Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, March 11, 2019 – Choice Canning Company, Inc., a Pittston, Pa. establishment, is recalling approximately 35,459 pounds of chicken fried rice 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 fried rice products were produced on Feb. 13, 2019 and Feb. 19, 2019. The following products are subject to recall: [View Labels (PDF only)]

  • 22 oz. printed polybag of “FUSIA Asian Inspirations, Chicken Fried Rice, Complete Skillet Meal,” with a packaging date of 2/13/2019, and a Best if Used By date of 08/13/2020 on the label.
  • 22 oz. printed polybag of “FUSIA Asian Inspirations, Chicken Fried Rice, Complete Skillet Meal,” with a packaging date of 2/19/2019, and a Best if Used By date of 08/19/2020 on the label.

The products subject to recall bear establishment number “P-45217” inside the USDA mark of inspection. These items were shipped to retail locations in California, Connecticut, Florida, Georgia, Minnesota, New York, Pennsylvania, Texas and Virginia.

The problem was discovered on March 11, 2019 by FSIS personnel during routine label verification.

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.

(more…)

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

Summary

Company Announcement Date:
March 11, 2019
FDA Publish Date:
May 20, 2019
Reason for Announcement:
Company Name:
Claire’s Stores
Brand Name:
Claire’s
Product Description:
Makeup

Company Announcement

Out of an abundance of caution, today Claire’s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire’s Eye Shadows, Claire’s Compact Powder and Claire’s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences.

The products are no longer available in our stores, but may still be in the homes of consumers. The SKUs/Lots being recalled are:

  • Claire’s Eyeshadows, UPC #888711847165, SKU #84716, Lot No. 08/17
  • Claire’s Compact Powder, UPC #888711839153, SKU #83915, Lot No. 07/15
  • Claire’s Contour Palette, UPC #888711401947, SKU #40194, Lot No. 04/17

The SKUs and UPCs can be found on the price tickets affixed to the products, and all batch numbers are shown on the back panels below the ingredient lists.

All three products were offered for sale between October 2016 and March 2019 and have been removed from the marketplace. They were sold in Claire’s stores nationwide and on www.claires.com. External Link DisclaimerAny consumers who have purchased these products should discontinue use and return them to a Claire’s store for a full refund.

To date, Claire’s is not aware of any adverse reactions, injuries or illness caused by the possible presence of asbestos in the recalled products. Claire’s continues to have confidence in the safety and composition of its products and is taking these actions out of an abundance of caution. We are working with FDA to ensure the agency and our customers share that confidence. (more…)

Conagra Brands, Inc. Recalls Chicken and Rice Products Due To Misbranding and Undeclared Allergens

Class I Recall 025-2019
Health Risk: High Mar 9, 2019

Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
Press@fsis.usda.gov

 

WASHINGTON, March 9, 2019 – Conagra Brands, Inc., a Milton, Pa. establishment, is recalling approximately 2,871 pounds of chicken and rice products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products may contain milk and wheat, known allergens, which are not declared on the product label.

The products are labeled as chicken and rice products but contain beef ravioli products.  The products were produced and packaged on Jan. 16, 2019. The following products are subject to recall: [View Labels (PDF only)]

  • 7.5 oz. canned microwavable bowls of “Chef BOYARDEE rice with chicken & vegetables” on the label, and a package code of 210090151050045L, and ‘BEST BY’ date of Jul082020 on the bottom of the bowl.

The products subject to recall bear establishment number “EST. 794” on the bottom of the bowl. These items were shipped to retail locations in Florida, Kentucky and New York.

The problem was discovered by the firm after receiving consumer complaints that  bowls of microwave beef ravioli were mislabeled as “chicken with rice & vegetables.” FSIS was notified on March 8, 2019.

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.

(more…)

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk

Summary

Company Announcement Date:
March 08, 2019
FDA Publish Date:
March 18, 2019
Product Type:
Food & Beverages
Produce
Reason for Announcement:
Company Name:
Fullei Fresh
Brand Name:
Fullei Fresh
Product Description:
Organic Bean Sprouts

Company Announcement

Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, an organism which 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.

Organic Bean Sprouts were shipped to Whole Foods Markets in Florida and Freedom Fresh (a Miami distributor) on February 18, 2019.

The product is packaged as 4 oz. in plastic clamshells. It has a lot code 041 and a sell by date of February 28, 2019. This information is printed in black ink on the package label. The UPC code is 017442052108.

To date, Fullei Fresh has not been informed of any illnesses associated with this recall. (more…)

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Summary

Company Announcement Date:
March 07, 2019
FDA Publish Date:
March 18, 2019
Reason for Announcement:
Company Name:
American Health Packaging
Brand Name:
Aurobindo Pharma USA, Inc.
Product Description:
Valsartan Tablets USP

Company Announcement

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging.

Valsartan Tablets USP are indicated to control high blood pressure and for the treatment of heart failure. Patients who prescribed Valsartan Tablets USP should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date. (more…)

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

Summary

Company Announcement Date:
March 07, 2019
FDA Publish Date:
April 29, 2019
Reason for Announcement:
Company Name:
Norbrook Laboratories Limited
Brand Name:
Norbrook
Product Description:
Enroflox® 100 Injection, Noromectin® Injection, Ivermax® 1% Injection

Company Announcement

March 7, 2019, Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox® 100 Injection (enrofloxacin), two lots of Noromectin® Injection (ivermectin) and two lots of Ivermax® 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs.

Norbrook Laboratories Limited discovered that product tested, released and distributed within the USA was manufactured on an aseptic line that subsequently did not pass process simulation tests. To date, Norbrook Laboratories Limited has not received any reports of adverse events related to this recall. (more…)

Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination

Class I Recall 024-2019
Health Risk: High Mar 2, 2019

Congressional and Public Affairs
Benjamin Bell
(202) 720-9113
Press@fsis.usda.gov

 

EDITOR’S NOTE: 
– This release is being updated to include additional information and a corrected product information list.

WASHINGTON, March 2, 2019 – Washington Beef, LLC, a Toppenish, Wash. establishment, is recalling approximately 30,260 pounds of ground beef chubs products that may be contaminated with extraneous materials, specifically hard plastic and metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ground beef chubs were produced on Dec. 27, 2018 and include a “Use or Freeze by” date of 01/20/19. The following products are subject to recall: [View Labels (PDF only)]

  • See attached spreadsheet here.

The products subject to recall bear establishment number “EST. 235” inside the USDA mark of inspection. These items were shipped nationwide.

The problem was discovered by a consumer complaint to the company on February 28, 2019.

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.

(more…)

Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella

Summary

Company Announcement Date:
March 01, 2019
FDA Publish Date:
May 09, 2019
Product Type:
Dietary Supplements
Nutritional Supplement
Reason for Announcement:
Company Name:
Sunstone Organics
Brand Name:
Sunstone Organics
Product Description:
White Vein Kratom and Maeng Da Kratom

Company Announcement

Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella.

Risk Statement: The product potentially could result in contracting salmonella. Symptoms of salmonella can include illness, vomiting, and some cases even death. This risk is higher for users a compromised or weak immune system, including elderly and young children. Sunstone Organics has not received any reports of adverse events to date related to this recall. (more…)

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Summary

Company Announcement Date:
March 01, 2019
FDA Publish Date:
April 29, 2019
Product Type:
Drugs
Reason for Announcement:
Company Name:
Torrent Pharmaceuticals Limited
Brand Name:
Torrent Pharma
Product Description:
Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP

Company Announcement

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

The impurity detected in the API is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. (more…)