Tag Archives: Recall

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.

Hawaii Firm Recalls Frozen Pork Products Due To Misbranding and Undeclared Allergen

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WASHINGTON – Kulana Foods Ltd., a Hilo, Hawaii establishment is recalling approximately 4,465 pounds of frozen, fully cooked pork products because of misbranding and an undeclared allergen. The products are formulated with a soy sauce that contains wheat, a known allergen, which is not declared on the label.

This is a Class II Recall which presents a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

The products subject to recall include:

  • Various weight (approximately .75 – .90 lb.) packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case codes: 03414, 07214, 12814, 16914, 21114, 28114, 03713, 05113, 06513, 23313, or 34513.
  • 5-pound packages of “MOUNTAIN APPLE BRAND Teri Smoked Pork” with identifying case code: 09214.

The products bear the establishment number “EST. 12445” inside the USDA mark of inspection on the label. The products were produced on various dates between Feb. 6, 2013 and Oct. 8, 2014 and shipped to retail locations and for foodservice use on the islands of Hawaii and Oahu.

The problem was discovered by FSIS personnel during a label review at the establishment. FSIS personnel are responsible for verifying that establishments are actively labeling the eight most common food allergens. Wheat was a sub-ingredient of soy sauce used in the product and was inadvertently left off the product label.

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.

Marin Food Specialties, Inc. Initiates Voluntary Recall of Imported Organic Raw Almonds (Bitter Almonds)

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Due to Elevated Levels of Naturally Occurring Hydrogen Cyanide
raw-almonds
Marin Foods Specialties, Inc. of Byron, CA is voluntarily recalling Organic Raw Almonds (bitter almonds), due to them possibly containing elevated levels of naturally occurring hydrogen cyanide according to laboratory test results. To date, no human illnesses have been associated with these products and they have been pulled from sale.

Bitter almonds are the wild form of the edible “sweet almonds.” Bitter almonds contain a chemical called glycoside amygdalin, which becomes transformed into toxic prussic acid (hydrogen cyanide) after they are crushed or chewed. Eating foods that contain prussic acid may result in some or all of the following signs and clinical symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness, and weakness. Exposure to higher quantities of food containing prussic acid may cause other more serious health effects including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death. Showing these signs and symptoms does not necessarily mean that a person has been exposed to cyanide. Treatment with supportive measures and available specific and efficacious antidotes frequently allows survival.

The products were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Market Organic Raw Almonds Imported from Spain,” and were packaged in 13.5 oz. plastic tubs. The recalled products have sell-by dates from 4/18/15 to 6/7/15 and a UPC code of UPC 9-99482-00071-7. The recalled product was distributed to Whole Foods Market stores only in Northern California, Oregon, Washington, Reno, Nevada and Boise, Idaho.

Bartlett Milling Company Issues Recall of Horse Food

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Bartlett Milling Company has initiated a limited recall of certain horse feeds due to potential Rumensin contamination. The products were distributed to customers and retailers in North Carolina, South Carolina, Tennessee and Virginia.

Rumensin contamination can result in health problems, including mortality, in horses. The products and lot number involved in the recall are:

  • 50 lb. bags of Bartlett Pasture Horse 10 Feed – Lot 288
  • 50 lb. bags of Cleveland Carolina Champion Horse Feed – Lot 288

The recalled products were packaged in typical brand-specific feed bags. Lot numbers are printed on the front and back of each bag.

Retailers have been contacted and instructed to immediately withdraw from sale the recalled product and to notify customers who purchased the product. Customers should discontinue feeding the product immediately. Customers who purchased this product should return remaining bags to their retailer.

For more information on the product recall, contact Bartlett Milling at 1-800-438-6016 from 8AM to 5PM Monday through Friday. Contact Bartlett at 1-336-655-1840 outside of regular business hours.

This recall is being conducted with the knowledge of the North Carolina Department of Agriculture & Consumer Services and the United States Food and Drug Administration.