Category Archives: Recall

Arizona Firm Recalls Chicken Breast Fritters Products

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poultry-1Primecut Meats, a Phoenix, Ariz. establishment, is recalling approximately 17,700 pounds of chicken breast fritters products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain eggs, a known allergen which are not declared on the product label.

  • 4 lb. boxes of “Prime Poultry Chicken Breast Fritters.”

The products subject to recall bear the establishment number “P-27220” inside the USDA mark of inspection. The items produced were shipped to retail locations in Arizona and Colorado.

The problem was discovered during routine FSIS in-plant verification activities.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers and media with questions about the recall can contact Chad Poppen, at (602) 455-8834.

Hospira Issues a Voluntary Nationwide Recall of Sodium Chloride Injection

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ucm430936LAKE FOREST, Ill., — Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall of one lot of  0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

This lot was distributed nationwide from September 2014 through November 2014. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. Hospira has notified its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For additional assistance, call Stericycle at 1-877-877-0164 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Hospira will provide allocation credits and make replacement product available for contracted customers.

For clinical inquiries, please contact Hospira using the information provided below.

Hospira Contact Contact Information Areas of Support
Hospira Global Complaint Management 1-800-441-4100 (8am-5pm CT, M-F)
(ProductComplaintsPP@hospira.com)		 To report adverse events
or product complaints
Hospira Medical
Communications		 1-800-615-0187 or medcom@hospira.com
(Available 24 hours a day/7 days per week)		 Medical Inquiries

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

Oma’s Pride Recalls Purr Complete Feline Poultry Meal

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oma-purr430728Oma’s Pride of Avon, CT is recalling Purr-Complete Feline Poultry Meal because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

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.

Purr-Complete Feline Poultry Meal was distributed nationwide through retail stores, distributors, and directly to consumers. Purr-Complete Feline Poultry Meal is sold frozen. It is packaged in clear 12 oz. (UPC: 8 79384 00017 9) and 2 lb. (UPC: 8 79384 00018 6) plastic packaging under the Oma’s Pride brand as a poultry blend with code #1524. It was manufactured on September 12, 2014 with a use by recommended date of September 12, 2015.

There have been no illnesses reported to date.

The recall was as the result of a routine sampling program by Pesticide and Plant Pest Management Division of the Michigan Department of Agriculture and Rural Development resulting in a positive test for Salmonella. Oma’s Pride has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem.

Consumers who have purchased Purr-Complete Feline Poultry Meal are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Oma’s Pride Monday through Friday, 9:00am – 4:30pm, at 1-800-678-6627.

Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio® and INRatio®2 PT/INR Monitor System

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WALTHAM, Mass. – Alere Inc. (NYSE:ALR) has initiated a voluntary correction to inform U.S. users of the Alere INRatio® and INRatio®2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio® Monitor or INRatio®2 Monitor and INRatio® Test Strips). In certain cases an INRatio® and INRatio®2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.

The INRatio® and INRatio®2 PT/INR Monitor system should not be used on patients with any of the following conditions:

  • Anemia of any type with hematocrit less than 30%
  • Any conditions associated with elevated fibrinogen levels including:
    • Acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
    • Chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
    • Severe infection (e.g., sepsis)
    • Chronically elevated fibrinogen for any reason
    • Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

Patients with any of the conditions listed above should immediately be transitioned to a laboratory INR method for monitoring their INR and warfarin therapy.

In addition, healthcare professionals and patient self-testers should adhere to the following precautions in order to obtain the most accurate results:

In addition to the precautions outlined above, Alere also recommends that patients have periodic verification of their INR using a laboratory INR method. Any patient having a significant discrepant low result on the INRatio® and INRatio®2 monitor system as compared to the plasma-based laboratory INR method should immediately be transitioned to an alternative method for monitoring their INR and warfarin therapy. Significant discrepancy in INR results may lead to a delay in an urgent medical decision to reverse a supratherapeutic INR level following the established guidelines for monitoring warfarin therapy. Such discrepancies are of particular concern when the erroneous INR result is within the therapeutic range but the actual value is supratherapeutic, i.e., when the actual INR value is 6 or greater.

Alere also recommends that patients be tested to verify that their hematocrit falls within the range of 30% to 55%. Patients with hematocrit outside this range should be immediately transitioned to a plasma-based laboratory INR monitoring method.

Alere is working on an improvement to the current INRatio® and INRatio®2 meter, which will serve to mitigate further the potential for these discrepant results.

As part of its commitment to ensuring the safety of patients, Alere has reported these device concerns to the U.S. Food and Drug Administration and is conducting a thorough investigation into these events.

Customers with questions regarding this recall can contact Alere at 1-877-929-2579. For additional information on the recall, including a list of product part numbers affected by the recall, customers should go to www.inr-care.com.

Adverse events 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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About the Alere INRatio® and INRatio®2 PT/INR Professional Monitoring System
The Alere INRatio® and INRatio®2 PT/INR Professional Monitoring System, consisting of the Alere INRatio® and INRatio®2 PT/INR Monitor and the Alere™ INRatio® Test Strip, is intended for use in the quantitative determination of International Normalized Ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio® and INRatio®2 PT/INR Professional Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio® and INRatio®2 PT/INR Monitoring System is not intended to be used for screening purposes and is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

For more information on Alere, please visit www.alere.com.

Safeway Recalls Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream

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safeway-select-ice-cream-18489PLEASANTON, Calif. — Safeway is voluntarily recalling Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream sold in all Safeway-owned stores from November 4, 2014 through December 5, 2014 due to the inclusion of an undeclared peanut allergen.

People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product. The recalled product is in a 1.5 quart package and displays the following UPC Code and Best Before Date.

Product Name UPC Code Best Before Date
Safeway Select French Salted Carmel (Fleur De Sel) Premium Ice Cream 21130 08970 Nov 03 2015

The UPC Code is located on the side panel. The Best Before Date is located on the bottom of the package.

No illnesses or injuries have been reported. The recipe’s caramel cups ingredient was replaced with peanut butter cups due to a supply error.

The recalled Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream was sold in all Safeway, Carrs, Genuardi’s, Pak ‘N Save, Pavilions, Randalls, Tom Thumb and Vons stores throughout the United States.

Customers are asked to discard the product or return it to their local store for a full refund. Customers who have questions about the recall can contact Safeway at 1-877-SAFEWAY.

Overhill Farms Voluntarily Recalls Open Nature Chile Cheese Enchiladas

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ucm425650WASHINGTON — Overhill Farms, Inc. of Vernon, California is voluntarily recalling the frozen food product Open Nature Chile Cheese Enchiladas due to potential Salmonella contamination. The supplier for the organic cilantro contained in such product notified Overhill Farms that the organic cilantro may have Salmonella contamination based on routine testing conducted. The product is sold nationwide at all Safeway-owned stores, including Safeway, Carrs, Genuardi’s, Pak ‘N Save, Pavilions, Randalls, Tom Thumb and Vons.

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.

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

Open Nature Chile Cheese Enchiladas are a frozen prepared dinner packaged in a box with a net weight of 9 oz. and marked with a UPC 0-7989310436-9. The product was sold at stores from Oct 9, 2014, through December 1, 2014.

Packages with the following lot code and “Best Before” dates are subject to the recall:

 
Lot Number Best By Date
141006 AUG-06-15

The lot number and best by date can be found on the side panel of the box.

Consumers should discard this product or return it to the store for a full refund. For additional information, please call Overhill Farms, Inc. at 1-323-582-9977 (Monday – Friday, 8:30 am – 4:30 pm PST) or Safeway at 1-800-SAFEWAY.

Nebraska Firm Recalls Pork Belly Product Produced Without Import Inspection

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WASHINGTON – Quality Meats, Inc., an Omaha, Neb., establishment, is recalling approximately 44,372 pounds of frozen pork belly product because they were not presented at the border for USDA-FSIS Import Inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. This is a Class I recall since the benefit of full inspection, a possibility of adverse health consequences exists.

Product subject to recall includes:

  1. Various weight cases of “rosderra IRISH MEATS Swine Pork Belly”

The Frozen Pork Single Ribbed Bellies product was packaged March 18, 2014 through April 10, 2014. The product subject to recall bears the Ireland establishment number “IE 356 EC.” This product was shipped to retail establishments and distributors in Georgia, Illinois, and Washington where the products would have been repackaged.

The problem was discovered during a routine review using the Automated Commercial Environment (ACE) database. ACE is a web-based portal for the collection and use of international trade data maintained by U.S. Customs and Border Protection.

FSIS and the company have received no reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.

FSIS issues a Public Health Alert for an imported product when the country of origin recalls the product. FSIS issues a recall for imported product when the product is not presented for inspection at the U.S. border.

A failure-to-present (FTP) occurs when importers fail to present a shipment to FSIS for import inspection prior to the product entering U.S. commerce. Failure-to-present will result in the recall of the product.

Recall of Northstar Label Gabapentin Capsules

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ucm424493Dayton, NJ, Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.

Empty capsules could result in missed dose(s) of gabapentin resulting in adverse health consequences that could range from no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening. Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall to date, but has received four complaints for empty capsules.

Gabapentin is used as in the treatment of epilepsy and for the management of postherpetic neuralgia (pain after shingles). The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.

Aurobindo Pharma USA, Inc. is notifying its distributors and customers by recall letters and is arranging for return of all recalled product. Consumers, distributors, and retailers that have product which is being recalled should stop using, distributing, or dispensing the affected lot and return to place of purchase.

Consumers with questions regarding this recall can contact Aurobindo Pharma USA Pharmacovigilance group at (732) 839-9400 Option 2 or PVG@aurobindousa.com Monday through Friday, 8:30AM to 5:00PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Great American Appetizers, Inc. Recalls Hyvee Mozzarella Cheese Sticks Due To Undeclared Soy Flour, Yellow #5, And Yellow #6

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640px-ucm423215Great American Appetizers, Inc. of Nampa, Idaho is recalling 662 cases of HyVee Mozzarella Cheese Sticks because they may contain undeclared soy flour, yellow #5 and yellow #6. People who have an allergy or sensitivity to soy, yellow #5 or yellow #6 can run the risk of serious allergic reaction if they consume this product.

The HyVee Mozzarella Sticks were distributed to retailers in Iowa, Illinois, Kansas, Minnesota, Missouri, Nebraska, South Dakota, and Wisconsin.

The HyVee Mozzarella Cheese Sticks affected are in an 8 oz. (227 g) carton (UPC #075450149913). The product date codes are printed on the end of the carton: 14290402 (BEST IF USED BY 4/17/2016) and 14295402 (BEST IF USED BY 4/22/2016). No other date codes are affected by this recall.

No illnesses have been reported to date.

This incident was discovered in-house by the company’s internal packaging review. Great American Appetizers, Inc. staff determined that the new carton did not accurately describe all allergens present in the product during the packaging update.

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

Consumers who have purchased HyVee Mozzarella Cheese Sticks may return them to the place of purchase for a full refund. Consumers with questions may contact the company at: 1-800-282-4834 from 8AM – 5PM Mountain Time, or email inquiries to KalaT@appetizer.com.

B&G Foods Issues Allergy Alert On Undeclared Peanut And Almond In Product

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B&G Foods announced today it is voluntarily recalling certain Ortega Taco Seasoning Mix, Ortega Taco Sauce, Ortega Enchilada Sauce and Ortega Taco Kit products and certain Las Palmas Taco Seasoning Mix and Las Palmas Taco Sauce products after learning that one or more of the spice ingredients purchased from a third party supplier contain peanuts and almonds, allergens that are not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts and almonds run the risk of serious or life-threatening allergic reaction if they consume these products.  There is no health risk associated with these products for individuals without an allergy to peanuts or almonds.

This recall affects the following products:

Consumer UPC # Size Best By Date Range Description
0 39000 00805 1 10oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00818 1 16.7oz May 18, 2015 – Feb 10, 2016 Ortega Taco Dinner Kit
0 39000 00820 4 1.25 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning
0 39000 00821 1 3.75 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Seasoning  (3 Pack)
0 39000 00860 0 5 lb. Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00861 7 9 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Meat Seasoning (Foodservice)
0 39000 00890 7 8 oz Feb 18, 2017  –  Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 00891 4 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 39000 01012 2 15.2oz May 18, 2015 – Feb 10, 2016 Ortega Soft Taco Dinner Kit
0 39000 01892 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 39000 01893 7 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Mild
0 39000 01894 4 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Medium
0 41501 00806 5 9.15oz May 18, 2015 – Feb 10, 2016 Ortega Whole Grain Taco Kit
0 41501 00824 9 1.25oz Feb 18, 2016-Nov 3, 2016 Ortega 40% Less Sodium Taco Seasoning
0 41501 00832 4 5oz May 18, 2015 – Feb 10, 2016 Ortega “Tacos for Two” Kit
0 41501 00882 9 144 g 15 MA 18- 16 FE 10 Ortega “Tacos for Two” Kit (Canada)
0 41501 00897 3 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Green Taco Sauce – Mild
0 41501 00898 0 8 oz Feb 18, 2017 – Nov 10, 2017 Ortega Enchilada Sauce
0 41501 00907 9 16 oz Feb 18, 2017-Nov 10, 2017 Ortega Green Taco Sauce  –  Mild
0 41501 01014 3 13.6 oz May 18, 2015-Feb 10, 2016 Ortega Whole Wheat Soft Taco Kit
0 41501 01015 0 21.3oz May 18, 2015 – Feb 10, 2016 Ortega Grande Hard & Soft Taco Dinner Kit
0 41501 01058 7 15.9oz May 18, 2015-Feb 10, 2016 Ortega Whole Grain/Whole Wheat  Hard & Soft Taco Kit
0 41501 01895 8 16 oz Feb 18, 2017 – Nov 10, 2017 Ortega Taco Sauce – Hot
0 41501 08351 2 9.8oz May 18, 2015 – Feb 10, 2016 Ortega Fiesta Flats Kit
0 41501 79811 9 3.75 oz Feb 18, 2016-Nov 3, 2016 Las Palmas Taco Seasoning Packet (3 Pack)
0 41501 79812 6 106 g 16 FE 18 –  16 NO 03 Las Palmas Taco Seasoning Packets (3 Pack) (Canada)
0 41501 79890 4 8 oz Feb 18, 2017-Nov 10, 2017 Las Palmas Taco Sauce (Mild)
0 41501 79990 1 226g 17 FE 18 – 17 NO 10 Las Palmas Taco Sauce (Mild) (Canada)
N/A .33 oz Feb 18, 2016 – Nov 3, 2016 Ortega Taco Sauce Packets (Foodservice)

The recalled products were distributed in retail stores and foodservice outlets nationwide.

This recall does not apply to any other sizes or varieties of Ortega Seasoning Mix or to any Ortega Seasoning Mixes in canisters, all of which are correctly labeled.  For example, this recall does not include Ortega Fajita Seasoning Mix, Ortega Fish Taco Seasoning Mix, Ortega Chili Seasoning Mix, Ortega Chipotle Seasoning Mix or Ortega Burrito Seasoning Mix, all of which are correctly labeled.  This recall also does not include any Las Palmas Enchilada Sauce, which is correctly labeled.

“The safety of our consumers is our number one priority.  We are committed to providing safe, quality products while observing the highest ethical standards in the conduct of our business,” said William Wright, Executive Vice President of Quality Assurance and R&D at B&G Foods.  “The core values that we’ve embodied since the company was founded in the 1800s — honesty, integrity and accountability — guide our actions as we take the appropriate measures to address this issue.”

This recall was initiated in consultation with the FDA after it was discovered that ingredients from a single supplier used in the affected products were contaminated with peanut and almond allergens. B&G Foods has since terminated its relationship with this supplier and is receiving these ingredients from other sources in anticipation of resuming production shortly.

Consumers who have purchased the recalled products are urged to return them to the place of purchase for a full refund.  Consumers with questions may contact the company’s recall hotline at 877-929-2576 from 8:00 a.m. ET to 8:00 p.m. ET, or visit www.ortega.com for additional information.