FDA/USDA~March ~2019~ Alerts & Safety


  • Aurora Packing Company, Inc., a North Aurora, Ill. establishment, is recalling approximately 4,838 pounds of beef heel and chuck tender products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The bulk beef products were produced and packed on Feb. 27, 2019. The following products are subject to recall: [View Labels (PDF only)]
    Varying catch weight cardboard box case packages containing bulk pieces of “AURORA ANGUS BEEF BONELESS BEEF – CHUCK TENDER” and case code 61150 represented on the label.
    Varying catch weight cardboard box case packages containing bulk pieces of “BONELESS BEEF – HEEL MEAT” and case code 29970 represented on the label.
    Varying catch weight cardboard box case packages containing bulk pieces of “BONELESS BEEF – HEEL MEAT” and case code 49970 represented on the label.
    The products subject to recall bear establishment number “EST. 788” inside the USDA mark of inspection. These items were shipped for institutional use in Illinois, Iowa, and Wisconsin. Consumers and members of the media with questions about the recall can contact David Stewart, Director of Sales and Marketing for Aurora Packing Company, Inc., at (630) 897-0551.
  • Henry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores because they have the potential to be contaminated with Listeria monocytogenes. Henry Avocado is issuing this voluntary recall out of an abundance of caution due to positive test results on environmental samples taken during a routine government inspection at its California packing facility. There are no reported illnesses associated with this recall.
    The recalled products – California-grown conventional and organic avocados — were packed at Henry Avocado’s packing facility in California and distributed in Arizona, California, Florida New Hampshire, North Carolina and Wisconsin. All shipments from the packing facility are subject to the recall (Henry Avocado did not begin packing there until late January 2019). Avocados imported from Mexico and distributed by Henry Avocado are not subject to the recall and may continue to be sold and consumed.Henry Avocado is contacting all affected customers to confirm that the recalled products are immediately removed from store shelves. For conventional products purchased at retail, consumers can identify the recalled products by the “Bravocado” stickers. Henry Avocado organic products do not carry the “Bravocado” label on the sticker. Instead those products are labeled “organic” and include “California” on the sticker. Retailers can identify Henry Avocado organic products by the bar code on the stickers.
    Consumers who have purchased any recalled avocados are urged not to consume them, but to discard them or return them to the place of purchase for a full refund. Consumers with further questions may contact Henry Avocado at (760) 745-6632, Ext 132 or visit http://www.henryavocado.com/media
    Henry Avocado Corporation is fully cooperating with federal and California health officials to facilitate an efficient and complete recall of these avocados.
    “We are voluntarily recalling our products and taking every action possible to ensure the safety of consumers who eat our avocados,” says Phil Henry, President of Henry Avocado.
  • Tip Top Poultry, Inc., a Rockmart, Ga. establishment, is recalling approximately 100 pounds of frozen, fully cooked diced white chicken meat 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 soy, a known allergen, which is not declared on the product label.
    The products are labeled as fully cooked diced white chicken meat products but contain fully cooked grilled chicken breast strips products. The products were produced on February 15, 2019. The following products are subject to recall:
    10-lb. case containing two 5-lb. plastic bag packages of “Gordon™ CHOICE All Natural* Diced White Chicken Meat,” case code 599697, and “PACKDATE 02/15/19.”
    The products subject to recall bear establishment number “P-17453” inside the USDA mark of inspection. These items were shipped to a distributor in Michigan.
    The problem was discovered after the firm received a complaint from a customer that they received fully cooked grilled chicken strips instead of fully cooked diced white chicken meat. FSIS was notified on March 22, 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. Consumers and members of the media with questions about the recall can contact Terry Bruce, senior vice president of quality operations for Top Tip Poultry, Inc., at (770) 973-8070.
  • North Country Smokehouse, a Claremont, N.H. establishment, is recalling approximately 2,686 pounds of ready-to-eat sausage 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 ready-to-eat kielbasa sausage items were produced on February 7, 2019 and February 8, 2019. The following products are subject to recall: [View Labels (PDF only)]
    1-lb. vacuum-packed packages containing “NORTH COUNTRY SMOKEHOUSE ORIGINAL OLD FASHIONED POLISH STYLE KIELBASA” with “USE BY 05/09/19.”
    12-oz. vacuum-packed packages containing “NORTH COUNTRY SMOKEHOUSE *NATURAL OLD FASHIONED POLISH STYLE KIELBASA” with “USE BY 04/23/19.”
    1-lb. vacuum-packed packages containing “KILCHURN ESTATE® SMOKED KIELBASA” with “USE BY 05/09/19.”
    The products subject to recall bear establishment number “EST. 5390A” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.
    The problem was discovered on March 18, 2019 by FSIS inspection program personnel during a routine review of establishment consumer complaint records.
    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 with questions about the recall can contact Daniel Sarapin, quality assurance manager, North Country Smokehouse, at (603) 543-0234 ext. 207. Members of the media with questions about the recall can contact Alicia Baker, brand manager, North Country Smokehouse, at (603) 543-0234 ext. 214.
  • Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG™/health NATURALS baby Cough Syrup + Mucus.
    The recalled DG™/health NATURALS baby Cough Syrup + Mucus” bottles were distributed nationwide in Dollar General retail stores. The product comes in a carton labeled DG™/health baby Cough Syrup + Mucus in 2-fluid ounce bottles marked with Lot KL180157 Expiration date 11/20 on the bottom of the carton and back of the bottle label; UPC Code 8 54954 00250 0.Consumers who have purchased Lot KL180157 of DG™/health NATURALS baby Cough Syrup + Mucus” may return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-844-724-7347 8:30 a.m. to 6:00 p.m. EST or e-mail at Christina.Condon@SciRegs.com.
  • Two Brothers Pork Skins, a Kannapolis, N.C. establishment, is recalling an undetermined amount of pork skin products because the products were produced without meeting the federal requirements to develop and implement a hazard analysis and system of preventive controls to improve the safety of the products, known as Hazard Analysis and Critical Control Points; the omission of safe handling instructions on the package; and due to misbranding, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The pork skins items were produced on various unknown dates. The following products are subject to recall: [View Labels (PDF only)]
    16-oz. (1-lb.) plastic (semi-translucent) containers of “TWO BROTHERS DOS HERMANOS CUERITOS PORK SKIN IN BRINE” on the label.
    1-lbs. (16-oz.) clear, vacuum sealed packages containing “TWO BROTHERS DOS HERMANOS CHiCHARRON PRENSADO Fried Pork Skins” on the label.
    15-lbs. (240-oz.) clear, vacuum sealed packages containing “TWO BROTHERS DOS HERMANOS CHiCHARRON PRENSADO Fried Pork Skins” on the label.
    The Prensado products contained tomato puree, chorizo powder, vinegar, orange juice, garlic, black pepper, onion and spices, which were not declared on the product labels.
    The products subject to recall bear establishment number “EAST. 40259” inside the USDA mark of inspection. These items were shipped to a distributor and retail locations in North Carolina and South Carolina.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 and members of the media with questions about the recall can contact Margarita Moran, Two Brothers Pork Skins owner, at (704) 619-8639 or via email at MargaritaMoran75@yahoo.com.
  • BLUEFUSION Capsules by Ata Int.: Recall – Due to Presence of Undeclared Sildenafil, Tadalafil, Desmethyl Carbodenafil, Dithiodesmethyl Carbodenafil, Scutellarin and DaidzeinAUDIENCE: Consumer, Pharmacy, UrologyISSUE: Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein
  • DG/Health NATURALS Baby Cough Syrup + Mucus by Kingston Pharma: Recall – Possible Health RiskAUDIENCE: Consumer, Pediatrics, PharmacyISSUE: Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/Health NATURALS Baby Cough Syrup + Mucus because it has the potential to be contaminated with bacillus cereus/ bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG/Health NATURALS Baby Cough Syrup + Mucus.
  • Venclexta (venetoclax): Risks Associated with the Investigational Use of Venclexta in Multiple MyelomaAUDIENCE: Oncology, Health Professional, PatientISSUE: FDA reviewed data from the BELLINI clinical trial (NCT02755597, Study M14-031) evaluating the use of Venclexta combined with bortezomib, a proteasome inhibitor, and dexamethasone in patients with multiple myeloma. The interim trial results demonstrated an increased risk of death for patients receiving Venclexta as compared to the control group. On March 6, 2019, the FDA required no new patients be enrolled on the Bellini trial. Patients who are receiving clinical benefit can continue treatment in the trial after they reconsent.This statement does not apply to patients taking Venclexta for an approved indication. Patients taking Venclexta for an approved indication should continue to take their medication as directed by their health care professional. Venclexta is safe and effective for its approved uses.
  • Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 69,093 pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, ready-to-eat chicken strip items were produced on November 30, 2018. The following products are subject to recall: [View Labels (PDF only)]
    25-oz. plastic bag packages of frozen “Tyson FULLY COOKED BUFFALO STYLE CHICKEN STRIPS CHICKEN BREAST STRIP FRITTERS WITH RIB MEAT AND BUFFALO STYLE SAUCE” with “BEST IF USED BY NOV 30 2019,” case codes 3348CNQ0317 and 3348CNQ0318, and individual bag time stamps from 17:00 through 18:59 hours (inclusive).
    25-oz. plastic bag packages of frozen “Tyson FULLY COOKED CRISPY CHICKEN STRIPS CHICKEN BREAST STRIP FRITTERS WITH RIB MEAT” with “BEST IF USED BY NOV 30 2019,” case codes 3348CNQ0419, 3348CNQ0420, 3348CNQ0421, and 3348CNQ0422, and individual bag time stamps from 19:00 through 22:59 hours (inclusive).
    20-lb. cases of frozen “SPARE TIME FULLY COOKED, BUFFALO STYLE CHICKEN STRIPS CHICKEN BREAST STRIP FRITTERS WITH RIB MEAT AND BUFFALO STYLE SAUCE” with “BEST IF USED BY NOV 30 2019,” and case code 3348CNQ03.
    The products subject to recall bear establishment number “P-7221” on the back of the product package. For product clarification, the last two digits of the product case codes correspond to the hour produced and will match the first two numbers of the time stamp (as depicted on the label). These items were shipped to retail locations nationwide and for institutional use in locations in Michigan and Washington.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.
  • La Rosita Fresh Market Inc., a Mt. Prospect, Ill. retail store, is recalling approximately 54 pounds of raw ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The raw ground beef items are ground in the store and packaged for consumers behind the meat counter in varying weights. The raw ground beef items were packed on March 13, 2019 and March 14, 2019. The following products are subject to recall:
    Varying weights of ground beef packed in white trays with plastic wrap, containing “MOLIDA DE RES GROUND BEEF” with “Packed On 3/13/19 Sell By 3/20/19” or “Packed On 3/14/19 Sell By 3/21/19”.
    These items were only sold in the La Rosita Fresh Market Inc. retail store, located at 1805 W. Algonquin Rd., Mt. Prospect, IL, 60056.
    The problem was discovered on March 14, 2019, by FSIS investigators through routine product sampling. There have been no confirmed reports of adverse reactions due to consumption of these products.There have been no confirmed reports of adverse reactions due to consumption of these products.Consumers and members of the media with questions about the recall can contact Diane Perez, General Manager at La Rosita Fresh Market Inc., at (847) 305-0710
  • Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter
    Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.
    The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.
  • Productos La Aguadillana, Inc., an Aguadilla, Puerto Rico establishment, is recalling approximately 35,870 pounds of breaded chicken patty products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The breaded chicken patty items were produced on February 27, 2019 and March 1, 2019. The following products are subject to recall: [View Label (PDF only)]
    10-lb. boxes containing 47 portions of “Productos La Aguadillana, Inc. Breaded Chicken Patty,” with a case code of TCE03060A, a packaging date of 03/01/2019, and an expiration date of 02/29/2020 represented on the label.
    10-lb. boxes containing 47 portions of “Productos La Aguadillana, Inc. Breaded Chicken Patty,” with a case code of TCE03058A, a packaging date of 02/27/2019, and an expiration date of 02/27/2020 represented on the label.
    The products subject to recall bear establishment number “P-7360” inside the USDA mark of inspection. These items were shipped to institutions in Puerto Rico. While the product was distributed to schools, it resulted from a commercial sale and was not part of food provided by USDA for the National School Lunch Program.
    There have been no confirmed reports of adverse reactions due to consumption of these products.Consumers and members of the media with questions about the recall can contact Luis Alvarez, president of Productos La Aguadillana, Inc., at (787) 891-5720.
  • Procesadora La Hacienda, Inc., a San Lorenzo, Puerto Rico establishment, is recalling approximately 4,940 pounds of ready-to-eat (RTE) corned beef products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.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.
    The RTE corned beef items were produced on Feb. 28, 2019. The following products are subject to recall: [View Labels (PDF only)]
    10-lb. boxes containing two 5-lb. packages of “Productos La Hacienda,” with lot code 022819 and expiration date of “Exp. 042919.”
    The products subject to recall bear establishment number “EST. 21217A” inside the USDA mark of inspection. These items were shipped to institutions in Puerto Rico. While the product was distributed to schools, it resulted from a commercial sale and was not part of food provided by the USDA for the National School Lunch Program.
    Consumers and members of the media with questions about commercially produced food products affected by the recall can contact Wilfredo Figueroa, vice president of Procesadora La Hacienda, at (787) 612-7276.
  • Surtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
    Products were distributed to retail food stores and specialty Latino food store in Western Washington between February 16, 2019 and March 2019.
    Products are sold under brand Surtidoras Bakery and packaged in a rigid plastic clam shell container, net weight 1.74 lbs. There is no UPC on label. The affected SELL By dates are listed below:
    Marble Muffin: Sell by dates between 3/18/19 and 3/26/19.
    Banana Muffin: Sell by dates between 3/19/19 and 3/26/19
    Blueberry Muffin: Sell by dates between 3/18/19 and 3/26/19.
    No illnesses have been reported to date.Consumers with questions may contact the company at 253-335-2324 from 8 am to 4 pm PST, Monday-Friday.
  • Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical.The product is used to treat high intraocular pressure and is packaged in 10 milliliter droptainers. The affected Pilocarpine 0.1% Ophthalmic Solution lots include the following lot number and expiration date:Product
    Lot Number
    Expiration Date
    Pilocarpine 0.1% Ophthalmic Solution
    R180052
    February 17, 2019
    The product was distributed in AL, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, NC, NJ, PA, VA, and WA to pet owners and veterinarian offices. Stokes Healthcare Inc. is notifying its customers by letter and phone and is arranging for the return and replacement of all recalled products. Consumers and veterinarian offices that have the Pilocarpine 0.1% ophthalmic solution that is being recalled should stop using the product immediately and contact Stokes Healthcare Inc. to arrange for return and replacement.
    Consumers with questions regarding this recall can contact Stokes Healthcare Inc. by phone at (856) 454-3368 or e-mail at RHamara@StokesHealthcare.com Monday-Friday 9AM -7PM and Saturdays 9AM-1PM; Eastern Standard Time. Consumers should contact their pet’s veterinarian if their pet has experienced any problems that may be related to taking or using this drug product.
  • Butterball, LLC, a Mount Olive, N.C. establishment, is recalling approximately 78,164 pounds of raw ground turkey products that may be contaminated with Salmonella Schwarzengrund, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The prepacked raw ground turkey was produced on July 7, 2018. The following products are subject to recall: [View Labels (PDF only)]
    48-oz. plastic wrapped tray containing “BUTTERBALL everyday Fresh Ground Turkey WITH NATURAL FLAVORING (85% LEAN/15% FAT)” with sell or freeze by date of 7/26/18, lot code 8188, and UPC codes 22655-71555 or 22655-71557 represented on the label.
    48-oz. plastic wrapped tray containing “BUTTERBALL everyday Fresh Ground Turkey WITH NATURAL FLAVORING (93% LEAN/7% FAT)” with sell or freeze by date of 7/26/18, lot code 8188 and UPC code 22655-71556 represented on the label.
    16-oz. plastic wrapped tray containing “BUTTERBALL everyday Fresh Ground Turkey WITH NATURAL FLAVORING (85% LEAN/15% FAT)” with sell or freeze by date of 7/26/18, lot code 8188 and UPC code 22655-71546 represented on the label.
    16-oz. plastic wrapped tray containing “BUTTERBALL everyday Fresh Ground Turkey WITH NATURAL FLAVORING (93% LEAN/7% FAT)” with sell or freeze by date of 7/26/18, lot code 8188 and UPC codes 22655-71547 or 22655-71561 represented on the label
    48-oz. plastic wrapped tray containing “Kroger GROUND TURKEY FRESH 85% LEAN – 15% FAT” with sell or freeze by date of 7/26/18, lot code 8188, and UPC code 111141097993 represented on the label.
    48-oz. plastic wrapped tray containing “FOOD LION 15% fat ground turkey with natural flavorings” with sell or freeze by date of 7/26/18, lot code 8188 and UPC code 3582609294 represented on the label.
    The products subject to recall bear establishment number “EST. P-7345” inside the USDA mark of inspection. These items were shipped to institutional and retail locations nationwide.
    FSIS and public health partners, including the Centers for Disease Control and Prevention (CDC), the Wisconsin Department of Health Services and Wisconsin Department of Agriculture, Trade and Consumer Protection, have been investigating a multistate outbreak of Salmonella Schwarzengrund illnesses involving 5 case patients from 2 states. Wisconsin collected three intact Butterball brand ground turkey samples from a residence where 4 of the case patients live. The case patients and ground turkey Salmonella Schwarzengrund isolates are closely related, genetically. Media with questions regarding the recall can contact Christa Leupen, Manager of Public Relations, at (919) 255-7598. Consumers should call (800) 288-8372.
  • WASHINGTON, March 13, 2019 – Monogram Meat Snacks, LLC, a Martinsville, Va. establishment, is recalling approximately 191,928 pounds of ready-to-eat pork sausage products that may be adulterated due to possible product contamination, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. This recall is being initiated due to product tampering, following the production process.
    The ready-to-eat pork sausages are heat-treated and shelf-stable. The items were produced and packaged for Conagra Brand / Duke’s Meats Corp. on various dates between Jan. 16 and March 7, 2019. The following products are subject to recall: [View Labels (PDF only)]
    5-oz. plastic pouches of “DUKE’S HICKORY PEACH BBQ SMOKED SHORTY SAUSAGES, Made with A PEACH BBQ RELISH,” that contain a package and case code of 1580002003, and various BEST IF USED BY dates from Jan. 16, 2019 through Jan. 27, 2020.
    5-oz. plastic pouches of “DUKE’S HOT & SPICY SMOKED SHORTY SAUSAGES, Made with FRESH-DICED SERRANO PEPPERS,” that contain a package and case code of 1601201052, and various BEST IF USED BY dates from Jan. 16, 2020 through Feb. 3, 2020.
    16-oz. plastic pouches of “DUKE’S ORIGINAL RECIPE SMOKED SHORTY SAUSAGES, Made with A CLASSIC BLEND OF SPICES & FRESHLY-CHOPPED HERBS,” that contain a package code of 1601201182, various BEST IF USED BY dates from Jan. 11, 2020 through Feb. 27, 2020, and a case code of 1580002130.
    5-oz. plastic pouches of “DUKE’S CAJUN STYLE ANDOUILLE SMOKED SHORTY SAUSAGES, Made with ROASTED RED PEPPERS & CAJUN SPICES,” that contain a package and case code of 1580002073, and various BEST IF USED BY dates from Jan. 10, 2020 through Feb. 13, 2020.
    5-oz. plastic pouches of “DUKE’S ORIGINAL RECIPE SMOKED SHORTY SAUSAGES, Made with A CLASSIC BLEND OF SPICES & FRESHLY-CHOPPED HERBS,” that contain a product and case code of 1601201051, and various BEST IF USED BY dates from Feb. 14, 2020 through Feb. 29, 2020.
    5-oz. plastic pouches of “DUKE’S HATCH GREEN CHILE SMOKED SHORTY SAUSAGES, Made with ROASTED & DICED HATCH CHILES,” that contain a package and case code of 1580002002, and various BEST IF USED BY dates from Jan. 13, 2020 through Feb. 3, 2020.
    5-oz. plastic pouches of “DUKE’S ORIGINAL RECIPE SMOKED SHORTY SAUSAGES, Made with A CLASSIC BLEND OF SPICES & FRESHLY-CHOPPED HERBS,” that contain a package code of 1601201051, various BEST IF USED BY dates from Feb. 17, 2020 through March 1, 2020, and a case code 1601201272.
    5-oz. plastic pouches of “DUKE’S HOT & SPICY SMOKED SHORTY SAUSAGES, Made with FRESH-DICED SERRANO PEPPERS,” that contain a package code of 1601201052, various BEST IF USED BY dates from Jan. 16, 2020 through Feb. 24, 2020, and a case code of 1601201274.
    The products subject to recall bear establishment number “EST. 795” inside the USDA mark of inspection. These items were shipped to retail locations nationwide.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 with questions about the recall may contact Gary Brooks, vice president of food safety quality assurance for Monogram Foods, at (855) 556-1351. Members of the media with questions about the recall can contact Alex DeWitt, communications coordinator for Monogram Foods, at (901) 681-9873.
  • Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241)because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.
    Roughly 12,245 cases of impacted Pillsbury® Unbleached All Purpose Flour product were distributed through a limited number of retailers and distributors nationwide. The only product lots affected by the recall are as follows:Item Name
    Case Item Code
    UPC Item Code
    Lot Code
    BIUB Date
    Pillsbury® Unbleached All-Purpose Flour
    5Lb
    0 5150022241 3
    0 5150022241 6
    8 292
    APR 19 2020
    Pillsbury® Unbleached All-Purpose Flour
    5Lb
    0 5150022241 3
    0 5150022241 6
    8 293
    APR 20 2020
    Other Best If Used By Dates and Lot Codes are not affected by this recall.
    There have been no reports of any illnesses associated with this recall. We apologize for the inconvenience this caused and are offering replacement coupons for your product. Please call our 800 number (1-800-767-4466). We remain committed to producing the high-quality products you expect.
  • 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. Consumers with questions may call (305) 758-3880 Monday through Friday 8:00 AM to 4:00 PM EST.
  • 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
  • Carnivore Meat Company, LLC, a Franklin, Tenn. establishment, is recalling approximately 379 pounds of raw ground beef and pork sausage 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 soy, a known allergen, which is not declared on the product label.
    The raw ground beef and pork sausage products were produced on Jan. 8, Jan. 28 and Feb. 7, 2019. The following products are subject to recall: [View labels (PDF only)]
    1 and 2-lb. vacuum sealed plastic packages of “Beef Boerewors, South African Farm Sausage.”
    1 and 2-lb. vacuum sealed plastic packages of “Traditional Boerewors, South African Farm Sausage.”
    The products subject to recall bear establishment number “EST. 45742” inside the USDA mark of inspection. These items were shipped to retail locations in Florida and Georgia. 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 and members of the media with questions about the recall can contact Carnivore Meat Company owner Virginia Botha at (615) 614-3134.
  • North Country Smokehouse, a Claremont, N.H. establishment, is recalling approximately 2,601 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. 2-oz. vacuum-sealed packages containing 4 pieces of “NORTH COUNTRY SMOKEHOUSE NATURAL IRISH BRAND BANGER SAUSAGE” and a use by date of 04/15/19 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. Consumers and members of the media with questions about the recall can contact Alicia Baker, brand manager for North Country Smokehouse at (603) 543-0234 Ext.214.
  • 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.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 with questions about the recall may call Frank Joyce, senior quality assurance manager for Choice Canning Company, at (570) 569-2662. Members of the media with questions about the recall can contact Nithin Poulose, vice president of operations for Choice Canning Company, at (732) 661-6400.
  • 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:
    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. he 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. 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 with questions about the recall may contact Danielle Richardson, Conagra’s manager of quality, at 1-(800) 921-7404. Members of the media with questions about the recall can contact Michael Cummins, Conagra’s vice president of communications, at (312) 549-5257
  • 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.
    Product Description
    AHP Lot No.
    Expiration Date
    Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
    Carton NDC#: 60687-139-01
    (Individual Dose NDC: 60687-139-11)
    179791
    3/31/2020
    American Health Packaging is notifying its distributors by recall letter sent March 6th, 2019 and to immediately discontinue distribution of the specific lots being recalled and to notify their sub- accounts. American Health Packaging is arranging for return of all recalled products to GENCO Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact any patients who may have received the recall lots and have them call (877) 475-5864 to receive a return packet. Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.
    Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
    1-866-850-2876 Option 2
    pvg@aurobindousa.com Any general questions regarding the return of this product please contact GENCO Pharmaceutical Services at (877) 475-5864 or (live calls received 9 am -5:00 pm Central Time).
  • USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry. WASHINGTON, March 7, 2019 — The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.
  • McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.
    Use of the contaminated product has a remote probability of necessitating medical or surgical intervention to preclude or reverse permanent damage to a body structure or function. To date, McDaniel Life-Line LLC has not received any reports of adverse events related to this recall.The product can be taken internally or applied externally to the skin. The product is packaged in 1-gallon bottles. The affected Life-Line Water recall includes all lots.
    The product was distributed in the United States and Canada to individuals via internet sales@lifelinewater.com.
    McDaniel Life-Line LLC is notifying its customers, by press release, of the recalled product. Consumers that have product which is being recalled should stop using and discard.
    Consumers with questions regarding this recall can contact McDaniel Life-Line by phone 806-647-1741, Monday thru Friday 8 AM-5 PM, Central Time or by e-mail lifeline@amaonline.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
  • 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.Product was distributed Nationwide to Wholesalers for use in hospital settings. No reports of injury or adverse events to date.
    Product Description
    AHP Lot No.
    Expiration Date
    Valsartan Tablets USP 160 mg, 100 count Unit Dose Blisters
    Carton NDC#: 60687-139-01
    (Individual Dose NDC: 60687-139-11)
    179791
    3/31/2020
    American Health Packaging is notifying its distributors by recall letter sent March 6th, 2019 and to immediately discontinue distribution of the specific lots being recalled and to notify their sub- accounts. American Health Packaging is arranging for return of all recalled products to GENCO Pharmaceutical Services. Instructions for returning recalled products are given in the recall letter. Pharmacies that have received the affected lot should contact any patients who may have received the recall lots and have them call (877) 475-5864 to receive a return packet. Consumers should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.Any general questions regarding the return of this product please contact GENCO Pharmaceutical Services at (877) 475-5864 or (live calls received 9 am -5:00 pm Central Time).
    Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at:
    1-866-850-2876 Option 2
    pvg@aurobindousa.com
  • MedWatch Safety Alert was just added to the FDA Medical Device Safety web page. TOPIC: LifeVest 4000 Wearable Cardioverter Defibrillator by Zoll: Safety Communication – Software Update AUDIENCE: Cardiology, Patient, Health Professional ISSUE: The FDA is reminding users of the Zoll LifeVest 4000 to contact the manufacturer immediately for a replacement device if their device displays the message: “Call for Service—Message Code 102.”FDA is also providing updated information on safety concerns related to the Zoll LifeVest 4000. Zoll is in the process of implementing a software update to all Zoll LifeVest devices to increase the prominence and persistence of the “Message Code 102” alert on the device’s display screen to help users identify and replace devices that may have an electrical issue which results in the device failing to deliver a shock to a patient if needed.
  • Updates• 013-2019, Richwell Group, Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection (Feb 5, 2019)
    • 020-2019, Bellisio Foods Recalls Boneless Pork Rib Frozen Entrée Products Due to Possible Foreign Matter Contamination (Feb 23, 2019)
  • MedWatch Safety Alert was just added to the FDA Medical Device Recall web page.TOPIC: Raindrop Near Vision Inlay by RVO 2.0: Class I Recall – Due to Risk of Increased Risk of Corneal HazeAUDIENCE: Patient, Eye Care, Health Professional, Risk ManagerISSUE: RVO 2.0 is recalling the Raindrop Near Vision Inlay because data from the post-approval study showed an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device. The device is now owned by RVO 2.0, doing business as Optics Medical.
  • Washington Beef is recalling 30,000 LBS of ground beefAs the memory of last year’s massive beef recalls begins to fade, another manufacturer is recalling 30,000 pounds of ground beef after learning of possible contamination.
    Washington Beef is recalling the products, after it learned “extraneous materials” could be comingled with the beef, said the Department of Agriculture’s Food Safety and Inspection Service over the weekend. Stories by Chris Morris and ktbsThe newly recalled beef was produced on Dec. 27 and has a “use or freeze by” date of Jan. 20, 2019. Officials are worried consumers might have stored some of this beef and it’s currently in their freezers. Consumers are urged to look for packages that have the establishment number “EST. 235”. inside the USDA mark of inspection.
    Here’s a list of the products being recalled:
    Double R Ranch 100% ground beef 1 lb. 90% lean/10% fat
    Double R Ranch 100% ground beef 1 lb. 85% lean/15% fat
    St. Helens 100% ground beef 1 lb. 90% lean/10 % fat
    St. Helens 100% ground beef 1 lb. 85% lean/15% fat
    St. Helens 100% ground beef 1 lb. 80% lean/20% fat
    St. Helens 100% ground beef 3 lb. 90% lean/10% fat
    St. Helens 100% ground beef 3 lb. 85% lean/15% fat
    St. Helens 100% ground beef 3 lb. 80% lean/20% fat
    St. Helens 100% ground beef 3 lb. 71% lean/27% fat
    Double R Ranch course ground beef chubs 10 lb. 80/20 (for institutional use only)
    SRF American wagyu beef fine ground beef chubs
    Beef boneless ground chuck blend smoked
    The recall comes after 2018’s JBS Tolleson beef recall, which was well over 5 million pounds of beef, due to salmonella fears. In November, the company also recalled 99,260 pounds of ground beef because of possible E. coli contamination. Competitor Cargill, meanwhile, was forced to twice recall meats last year, once in August and again in September.
  • 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. Sunstone Organics has not received any reports of adverse events to date related to this recall.
    The product is used as a tea or supplement and is packaged in kraft stand-up pouches in both capsule form and powder form, in 3 different size bags, for a total of 12 products. The affected Sunstone Organics Kratom lots include the following lot numbers: Sunstone Organics White Vein Lot 119 and Sunstone Organics Maeng Da Lot 124A in Powder form and package sizes 25 grams, 50 grams, and 100 grams, and in capsule form in sizes 20 count, 60 count, and 150 count. See table below for UPC codes:
    Sizes and Types
    Sunstone Organics Maeng Da Kratom Lot 124A
    Sunstone Organics White Vein Kratom Lot 119
    20 count Capsules
    00859667007149
    00859667007347
    60 count Capsules
    00859667007156
    00859667007354
    150 count Capsules
    00859667007163
    00859667007361
    25 gram Powder
    00859667007118
    00859667007316
    50 gram Powder
    00859667007125
    00859667007323
    100 gram Powder
    00859667007132
    00859667007330
    All 6 sizes pertain to the same lot number (i.e. Maeng Da Kratom Lot 124A or White Vein Kratom Lot 119). These products do not have an expiration date.
    The product can be identified by the kraft packaging with Sunstone Organics Kratom round label on the front of the package along with the strain type (i.e. White Vein, Maeng Da). Lot number (i.e. lot 119 or lot 124A) is provided on the back of the package. These products were distributed to retail outlets in Oregon, Washington, California, and Nebraska.
    Sunstone Organics is notifying its distributors and customers by visiting retail outlets on our distribution routes, phone calls to outlets we cannot visit, letters to all outlets, and a sign posted in all outlets notifying consumers, and is arranging for replacement of all recalled products. Consumers and retailers that have Sunstone Organics Kratom which is being recalled should stop using, discard or return to place of purchase.
    Consumers with questions regarding this recall can contact Sunstone Organics by phone at 541-972-3327 or by e-mail at info@sunstoneorganics.com. We are available by phone Monday-Friday from 8am to 6pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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