FDA/USDA~February ~2019~ Alerts & Safety


  • Fulton Seafood Inc., a Houston, Texas establishment, is recalling approximately 100,924 pounds of Siluriformes fish products, specifically wild caught catfish, because the products were produced, packed, and distributed without the benefit of federal inspection, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The wild caught catfish items were produced on various dates from Jan. 1, 2018 through Feb. 21, 2019. The following products are subject to recall: [View Labels (PDF only)]
    60-lb. brown cardboard boxes containing “River Catfish Wild USA.” Upon arrival at retail locations, the catfish were removed from boxes and placed in the seafood display case for consumer purchase.
    These items were shipped to retail locations within Texas. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Joe Massa, Sales Manager, Fulton Seafood Inc., at (713) 228-6931.
  • TV Food LLC., a San Leandro, Calif. non-federally inspected establishment, is recalling approximately 27,956 pounds of Siluriformes, specifically Yellow Hito (catfish), products because the products were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The following products are subject to recall: [View Labels (PDF only)]
    14-oz. vacuum-packed trays containing “Golden Boy, FROZEN FISH CA DONG CA TRE DONG” and “Packed By: MAI SAO Seafood Co., LTD.” printed on the label.
    14-oz. vacuum-packed trays containing “Golden Boy, FROZEN FISH STEAK CA TRE CAT KHUC” and “Packed By: MAI SAO Seafood Co., LTD.” printed on the label.
    12-oz. vacuum-packed trays containing “Golden Boy, FROZEN FISH CA DONG CA TRE DONG LAM SACH KHONG DAU” and “Packed By: MAI SAO Seafood Co., LTD.” printed on the label.
    2 Fish/Bag Sold by weight vacuum-packed trays containing “Golden Boy, FROZEN FISH CA DONG CA TRE VANG LAM SACH KHONG DAU” and “Packed By: MAI SAO Seafood Co., LTD.” printed on the label.
    3 Fish/Bag, Sold by Weight vacuum-packed trays containing “Golden Boy, FROZEN FISH CA DONG CA TRE VANG” and “Packed By: MAI SAO Seafood Co., LTD.” printed on the label.
    2-lbs. vacuum-packed trays containing “Golden Boy” yellow catfish.
    These items were shipped to distributor in Chicago, Ill. and to other locations nationwide. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider. Consumers and members of the media with questions about the recall can contact Fanny Chen, Owner, TV Food LLC., at (510) 878-7906.
  • Sahlen Packing Company, Inc., a Buffalo, N.Y. establishment, is recalling approximately 13,224 pounds of ready-to-eat (RTE) deli ham products that may be contaminated with extraneous materials, specifically plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The RTE deli ham items were produced on January 25, 2019. The following products are subject to recall: [View Labels (PDF only)]
    Varying weights of whole hams sliced and sold by weight at retail deli counters containing “MARKET 32 BY PRICE CHOPPER BLACK FOREST HAM with natural juices caramel color added 97% FAT FREE” and a sell by date of 4/8/19 represented on the label.
    The whole ham products subject to recall bear establishment number “EST. 5155” inside the USDA mark of inspection. These items were shipped to retail locations in Connecticut, Massachusetts, New Hampshire, New York, Pennsylvania, and Vermont.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 Joseph Sahlen Sr., owner, Sahlen Packaging Company, Inc. at (716) 852-8677.
  • Updates• 001-2019, J. H. Routh Packing Co. Recalls Pork Sausage Products due to Possible Foreign Matter Contamination, (Jan. 9, 2019)
    • 005-2019, Custom Made Meals, LLC Recalls Chicken Skewer Products Due to Misbranding and Undeclared Allergens, (Jan. 18, 2019)
  • VICS Acquisition, LLC, a Harlingen, Texas, establishment, is recalling approximately 99,975 pounds of chicken 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 eggs, a known allergen, that is not declared on the product label.
    The happi foodi Bloody Mary Inspired Chicken, Southeast Grocers Brand Marsala Chicken and Southeast Grocers Brand Mediterranean Herb Chicken items were produced from Aug. 7 through Oct.15, 2018. The following products are subject to recall: [View Labels (PDF only)]
    21 oz. packages containing one frozen steam bag meal of “happi foodi BLOODY MARY INSPIRED CHICKEN” with lot codes 14528 and 15092 and use by dates of March 2, 2020 and April 15, 2020.
    21 oz. packages containing one frozen steam bag meal of “SE Grocers MARSALA CHICKEN” with lot codes 14177 and 14532 and use by dates of Feb. 8, 2020 and March 3, 2020.
    21 oz. packages containing one frozen steam bag meal of “SE Grocers MEDITERRANEAN STYLE HERB CHICKEN” with lot codes 14145 and 14531 and use by dates of Feb. 7, 2020 and March 4, 2020.The products subject to recall bear establishment number “P-34622” on the product packaging. The happi foodi items were shipped to retail locations nationwide and the Southeast Grocers Brand products were shipped to retail locations in Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina and South Carolina.
    A company that VICS Acquisition, LLC co-packs for discovered the problem on Feb. 8, 2019 during a label review. FSIS was notified on Feb. 9, 2019.Consumers with questions about the recall can contact Gary Laney, vice president of product innovation and quality for WaffleWaffle, LLC at 201-559-9806. Members of the media can contact Deb Corley, media relations director at WaffleWaffle at 201-559-9801.
  • J Bar B Foods, a Weimar, Texas establishment, is recalling approximately 51,188 pounds of ready-to-eat (RTE) cheddar smoked sausage products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains milk, a known allergen, which is not declared on the product label.
    The ready-to-eat “Cheddar Smoked Sausage” items were incorrectly labeled as “Original Smoked Sausage.” The items were produced on January 19, 2019. The following products are subject to recall: [View Labels (PDF only)]
    14-oz. vacuum-sealed packages of “H-E-B MADE IN TEXAS ORIGINAL Smoked Sausage” with a sell by date of 5/19/19 and lot code LN2 90149.
    The products subject to recall bear establishment number “7066A” inside the USDA mark of inspection. These items were shipped to retail locations in Texas. 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 Bonnie Hymen, Risk Coordinator, J Bar B Foods, at (830) 788-7511, ext. 271. Members of the media with questions about the recall can contact Pete Beckwith, Chief Marketing Officer, J Bar B Foods, at (323) 898-3087.
  • Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Dukkah in 2.5oz containers because of the potential of it containing glass pieces.
    The product is packaged in a circular tin can with a clear lid labeled as Jansal Valley Dukkah, packaged in 2.5 ounce sizes. The cases contain 6, 2.5 oz units each.
    Product best by date: 08/28/2020
    Product lot codes: Case – L2033968 and individual tins – L2034198
    Jansal Valley Dukkah was distributed Nationwide.
    No injuries have been reported to date in connection with this problem.
    Consumers who have purchased 2.5 ounce packages of Jansal Valley Dukkah, or your if company is in possession of it please destroy the above mentioned product.
    Consumers with questions may contact the company at 1-800-423-8333 at extension 168 or 119 between the hours of 9:00 am and 5:00 pm.
    About Sid Wainer & Son: Sid Wainer & Son, based in New Bedford, MA, has been the most prominent importer and distributor of specialty produce in the country since 1914. In addition to produce, Sid Wainer & Son offers artisanal cheese and specialty foods, including their exclusive Jansal Valley® Line. Sid Wainer & Son suppliers over 30,000 of the finest restaurants, hotels, gourmet shops, retailers, and caterers both domestically and internationally. To learn more about Sid Wainer & Son, visit http://www.Sidwainer.com.
  • Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.Smoked Alaska Seafoods, Inc. produces several species of smoked salmon in flexible retortable pouches, glass jars and black two-piece metal cans. The flexible retortable pouches are not affected by this recall.
    No illnesses have been reported to date. The recall was initiated as a result of an independent audit paid for by Smoked Alaska Seafoods, Inc. A review of the thermal processing records determined the recalled lot did not receive the prescribed thermal process and was therefore underprocessed. Consumers should destroy the product, return it to the place where purchased for a refund or contact Smoked Alaska Seafoods, Inc. for a refund or replacement.
    This recall is being made with the knowledge of US Food and Drug Administration and the Alaska Department of Environmental Conservation.
    Consumers who have purchased this product and have questions or need additional information should call the company at (907) 355-5533 from 8:00 AM to 8:00PM Alaska time.
    The Smoked Silver Salmon was sold to distributors throughout the state of Alaska primarily in gift stores in the Anchorage and Fairbanks area.Smoked Alaska Seafoods, Inc. produces several species of smoked salmon in flexible retortable pouches, glass jars and black two-piece metal cans. The flexible retortable pouches are not affected by this recall.
  • Kingston Pharma, LLC is voluntarily recalling all lots of “DG™ Baby Gripe Water herbal supplement with organic ginger and fennel extracts” to the consumer level due to the presence of an undissolved ingredient, citrus flavonoid.
    Use of the product should not be considered hazardous but could result in difficulty when swallowing the product for sensitive individuals. To date, Kingston Pharma LLC has received one report of a one-week old infant having difficulty when swallowing the product and three complaints attributed to the undissolved citrus flavonoid.
    The product is administered orally to infants and adults. The recall is for all lots. The product is packaged in 4-ounce amber bottles, white plastic caps with safety seals and provided with an oral syringe, with UPC Code 8 5495400246 3. The product was distributed throughout the United States by Dollar General Corporation.To report adverse reactions or quality problems experienced with the use of this product or to ask questions regarding this recall, contact Christina Condon or C. Jeanne Taborsky by phone toll free at 844-724-7347 or by e-mail Christina.Condon@SciRegs.com. Consumers should contact their physician or healthcare provider if they or their child have experienced any problems that may be related to taking or using this product.
  •  Nature’s Path Foods announced a voluntary recall of a specific production run of EnviroKidz Choco Chimps, Gorilla Munch and Jungle Munch cereals for they may contain undeclared gluten (wheat and barley). People who have a wheat allergy, celiac disease or sensitivity to gluten and wheat should not consume the cereals with the BEST BEFORE DATE listed below due to potential adverse health effects. Nature’s Path is also removing any affected cereals from customer store shelves and warehouses. The error was isolated to one facility and due to air contamination as a result of incorrect production scheduling. Other gluten-free Nature’s Path and EnviroKidz products are not impacted and are not part of this voluntary recall.

Consumers requesting a refund for the affected cereals should return the product to their retailer. Consumers may also contact Nature’s Path Consumer Services at 1-866-880-7284 (between Monday and Friday, 8:00 am to 4:30 pm PST) or email at ConsumerServices@naturespath.com.

  • Lean Culinary Services, LLC, a Hollywood, Fla. establishment, is recalling approximately 223 pounds of ready-to-eat (RTE) chicken salad products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The RTE chicken salad items were produced on February 12, 2019. The following products are subject to recall:
    14.9-oz. plastic tub packages containing “classic chicken salad Made with Bell & Evans White Meat Chicken” and a Best By date of 2-17-19.
    8-lbs plastic bags containing “classic chicken salad Made with Bell & Evans White Meat Chicken” and a Sell By date of 2-19-19 for use behind the deli counter.
    7.8-oz plastic tub packages containing “DeliverLean CLASSIC CHICKEN SALAD” and a Use By date of 2/17/19.
    5.5-oz plastic tub packages containing “DeliverLean CHICKEN SALAD BENTO BOX” and a Use By date of 2/17/19.
    The products subject to recall bear establishment number “P-46167” inside the USDA mark of inspection. These items were shipped to retail locations in Florida. 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.
    Media and consumers with questions regarding the recall can contact Tammy Martinez, VP of Client Services, at (312) 805-2230.
  • Updates • 014-2019, VICS Acquisition, LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens, (Feb. 10, 2019)
    • 015-2019, Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation, (Feb. 11, 2019)
  • Felt, OK, McDaniel Life-Line LLC is voluntarily recalling all lots of Indian Herb to the consumer level. This product is being recalled because it is marketed without an approved NDA/ANDA. The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury.The product can be taken internally or applied externally to abnormal skin growths. The product is packaged in 6 dram vials. The affected Indian Herb includes all lots. Product was distributed in the United States, Italy, Canada, Australia and Poland to individuals via internet sales@lifelinewater.com  Consumers with questions regarding this recall can contact McDaniel Life-Line by phone 806-647-1471 or by e-mail lifeline@amaonline.com, Monday thru Friday 8 AM-5 PM, Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
  • Panola County Processing, LLC, a Carthage, Texas establishment, is voluntarily recalling approximately 59 pounds of smoked sausage products due to a processing deviation that may have led to underprocessing of products, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The pork smoked sausage links and venison and pork sausage links items were produced on Jan. 29, 2019. The following products are subject to recall: [View Labels (PDF only)]
    1.3-lb. vacuum-packed packages containing four pieces of “PANOLA COUNTY PROCESSING, LLC Pork Smoked Sausage PC” with packaging dates of Jan. 30, 2019 and Jan. 31, 2019.
    1.3-lb. vacuum-packed packages containing four pieces of “PANOLA COUNTY PROCESSING, LLC Pork Hot Smoked Sausage PC” with packaging date of Jan. 31, 2019.
    1.3-lb. vacuum-packed packages containing four pieces of “PANOLA COUNTY PROCESSING, LLC Venison & Pork Smoked Sausage PC” with packaging date of Jan. 31, 2019.
    1.3-lb. vacuum-packed packages containing four pieces of “PANOLA COUNTY PROCESSING, LLC Venison & Pork Hot Smoked Sausage PC” with packaging date of Jan. 31, 2019.
    The products subject to recall bear establishment number “EST. 48219” inside the USDA mark of inspection. These items were distributed to a retail location in Texas.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 Jeff Davidson, owner of Panola County Processing, LLC, at 903-690-0430.
  • VICS Acquisition, LLC, a Harlingen, Texas, establishment, is recalling approximately 99,975 pounds of chicken 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 eggs, a known allergen, that is not declared on the product label.
    The happi foodi Bloody Mary Inspired Chicken, Southeast Grocers Brand Marsala Chicken and Southeast Grocers Brand Mediterranean Herb Chicken items were produced from Aug. 7 through Oct.15, 2018. The following products are subject to recall: [View Labels (PDF only)]
    1.5-lb. packages containing one frozen steam bag meal of “happi foodi BLOODY MARY INSPIRED CHICKEN” with lot codes 14528 and 15092 and use by dates of March 2, 2020 and April 15, 2020.
    1.5-lb. packages containing one frozen steam bag meal of “SE Grocers MARSALA CHICKEN” with lot codes 14177 and 14532 and use by dates of Feb. 8, 2020 and March 3, 2020.
    1.5-lb. packages containing one frozen steam bag meal of “SE Grocers MEDITERRANEAN STYLE HERB CHICKEN” with lot codes 14145 and 14531 and use by dates of Feb. 7, 2020 and March 4, 2020.
    The products subject to recall bear establishment number “P-34622” on the product packaging. The happi foodi items were shipped to retail locations nationwide and the Southeast Grocers Brand products were shipped to retail locations in Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina and South Carolina.
    A company that VICS Acquisition, LLC co-packs for discovered the problem on Feb. 8, 2019 during a label review. FSIS was notified on Feb. 9, 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 with questions about the recall can contact Gary Laney, vice president of product innovation and quality for WaffleWaffle, LLC at 201-559-9806. Members of the media can contact Deb Corley, media relations director at WaffleWaffle at 201-559-9801.
  • World Waters, LLC is initiating a voluntary recall of certain lots of Cold Pressed Juice Watermelon WTRMLN WTR Original 12 packs due to the potential presence of soft plastic that may be loosely floating in some of the finished products. The product subject to this voluntary recall is found below. Watermelon Flavor
    AC02919
    Watermelon Flavor
    AW00219
    Watermelon Flavor
    AW00319
    Watermelon Flavor
    AW00419
    Watermelon Flavor
    AW00719
    Watermelon Flavor
    AW00919
    Watermelon Flavor
    AW01019
    Watermelon Flavor
    AW01419
    Watermelon Flavor
    AW01619
    Watermelon Flavor
    AW01719
    Watermelon Flavor
    AW01819
    Watermelon Flavor
    AW02419
    Watermelon Flavor
    AW34618
    Watermelon Flavor
    AW34718
    Watermelon Flavor
    AW35318
    Watermelon Flavor
    AW35418
    Watermelon Flavor
    AW36018
    Watermelon Flavor
    AW36118
    These products can be identified by the main label on the bottle and the lot number that is printed on the bottom of the bottle. The products were sent to customers nationwide for distribution via retail sales from December 22, 2018 – February 5, 2019.
    World Waters will provide consumers a coupon for replacement product upon proof of purchase. Consumers seeking replacement product or with questions regarding this recall can contact World Waters by calling Customer Service at 1-800-981-8973 Monday-Friday 9:00 a.m. to 5:00 p.m. MST or emailing the company at customercare@wtrmlnwtr.com.
  • Richwell Group, Inc., doing business as Maxfield Seafood, a City of Industry, Calif. firm and the importer of record, is recalling approximately 55,300 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen Siluriformes items, specifically Sheat fish, were imported from Vietnam to the United States on various dates from April 2018 through December 2018. The products have a shelf life of two years. The following products are subject to recall: [View Labels (PDF only)]
    14-oz. clear bag packages containing “Maxfield Seafood SHEAT FISH CA TREN KET” with “EXPIRY DATE” of 200324, 200403, 201007, 201008, 201113, 201115, 201222 and 201227.
    14-oz. clear bag packages containing “Maxfield Seafood SHEAT FISH CA TREN RANG” with “EXPIRY DATE” (some labels don’t display an expiration date) of 200324, 200403, 201007, 201008, 201113, 201115, 201222 and 201227.
    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 a reaction should contact a healthcare provider.  Consumers and members of the media with questions about the recall can contact Bradley Martin, General Manager/Vice President, Richwell Group, Inc., at (626) 964-8230.
  • Updates: • 004-2019, H & T Seafood, Inc. Recalls Siluriformes Products Produced without Benefit of Import Inspection (Jan. 18, 2019)
    • 007-2019, Harvest Food Group, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergen, (Jan. 25, 2019)
  •  Updates:  • 001-2019, J. H. Routh Packing Co. Recalls Pork Sausage Products due to Possible Foreign Matter Contamination, (Jan. 9, 2019)
    • 005-2019, Custom Made Meals, LLC Recalls Chicken Skewer Products Due to Misbranding and Undeclared Allergens, (Jan. 18, 2019)
  • Richwell Group, Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection http://bit.ly/2GpQT8M Richwell Group, Inc., doing business as Maxfield Seafood, a City of Industry, Calif. firm and the importer of record, is recalling approximately 55,300 pounds of Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen Siluriformes items, specifically Sheat fish, were imported from Vietnam to the United States on various dates from April 2018 through December 2018. The products have a shelf life of two years. The following products are subject to recall: [View Labels (PDF only)]
    14-oz. clear bag packages containing “Maxfield Seafood SHEAT FISH CA TREN KET” with “EXPIRY DATE” of 200324, 200403, 201007, 201008, 201113, 201115, 201222 and 201227.
    14-oz. clear bag packages containing “Maxfield Seafood SHEAT FISH CA TREN RANG” with “EXPIRY DATE” (some labels don’t display an expiration date) of 200324, 200403, 201007, 201008, 201113, 201115, 201222 and 201227.
    These items were shipped to retail locations nationwide.
    The problem was discovered on Jan. 30, 2019 during FSIS surveillance activities of imported products at the distributor facility.
    There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.  Consumers and members of the media with questions about the recall can contact Bradley Martin, General Manager/Vice President, Richwell Group, Inc., at (626) 964-8230.
  • Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.
    The recall, which began in October 2018, was originally initiated due to a product complaint received for mislabeling. The pre-printed text content on the infusion bag (primary container) for the lot indicates product information as Levetiracetam in 0.75% Sodium Chloride Injection (1000mg/100ml). The label on the external foil pouch has the product information as Levetiracetam in 0.54% Sodium Chloride Injection (1500mg/100ml). To date, there have been no reports of adverse events related to this recall.
    Patients who may have been administered the mislabeled product could experience adverse reactions such as somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma related to over dosage.
    Levetiracetam Injection is an antiepileptic drug indicated for adjunct therapy in adults (more than 16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures inpatients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures.
    The batch was distributed in U.S.A. between August 14, 2018 and September 5, 2018.
    The recalled batch is as follows:
    Item Description
    Manufacturer
    NDC
    Lot
    Expiry
    Date
    Levetiracetam in 0.54% Sodium chloride Injection, 1500mg/100mL
    Gland Pharmaceuticals
    43598-637-52
    ABD807
    05/2020
    Dr Reddy’s Laboratories, Inc has notified the distributors to arrange for return of any recalled product. Wholesalers, distributors, hospitals and pharmacies with an existing inventory of the lot being recalled, should stop use and distribution and quarantine the product immediately for return/replacement/etc. of all recalled products. Wholesalers, distributors and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-800-967-5952 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
    If patients have questions regarding this recall or to report an adverse event, please contact the Company’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 10 p.m. ET, Monday through Friday. Patients should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.
    Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm
    Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
  • Q’s American Best Trading Inc., a Lakewood, Calif. firm and the importer of record, is recalling approximately 1,008 pounds of imported Siluriformes fish products that were not presented for import re-inspection into the United States, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen Siluriformes, specifically Sheat fish, items were imported from Vietnam to the U.S. on Dec. 25, 2018. The following product is subject to recall: [View Labels (PDF only) There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.  Consumers and members of the media with questions about the recall can contact Julie Chai, manager, Q’s American Best Trading Inc., at (562) 366-6682.
  • General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product. This recall is being issued out of an abundance of care as General Mills has not received any direct consumer reports of confirmed illnesses related to this product.
    This recall only affects this one date code of Gold Medal Unbleached Flour five-pound bags. All other types of Gold Medal Flour are not affected by this recall.This voluntary recall includes the following code date currently in stores or consumers’ pantries:
    Gold Medal Unbleached All Purpose 5LB Flour
    Package UPC: 000-16000-19610-0
    Consumers are asked to check their pantries and dispose of the product affected by this recall. Consumers who have had to discard products covered by this recall may contact General Mills Consumer Relations at 1-800-230-8103 or visit http://www.generalmills.com/flour.
  •   Taylor Farms TX, Inc., a Dallas, Texas establishment, is recalling approximately 2,100 pounds of chicken products incorrectly labeled as “Chile Relleno” 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 wheat, a known allergen, which is not declared on the product label.
    The ready-to-eat “HEB Roasted Spaghetti Squash with Alfredo & Chicken” items were incorrectly labeled as “Chile Relleno.” The items were produced on various dates from Jan. 25, 2019 through Jan. 30, 2019. The following product is subject to recall: [View Labels (PDF only)]
    10-oz. tray packages labeled as “HEB-MEAL SIMPLE CHILE RELLENO” with “USE BY” dates of 02/04/2019, 02/05/2019, 02/07/2019, 02/08/2019, and 02/09/2019 and lot codes TFD025AU4, TFD026AU4, TFD028AU4, TFD029AU4 and TFD030AU4.
    The products subject to recall bear establishment number “EST. 34733” on the shipping container which is labeled as “HEB Roasted Spaghetti Squash with Alfredo & Chicken.” The chile relleno labels do not bear an establishment number. These items were shipped to distribution centers and retail stores in Texas.  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 Thomas Yongo, director of quality assurance with Taylor Farms Texas, at (855) 455-0098 or press@taylorfarms.com.
  • Nature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and thus can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
    Nature’s Rx has not received any reports of adverse events related to this recall.
    Nature’s Rx has not received any reports of adverse events related to this recall
    The product, Silver Bullet 10x, is used as a male enhancement nutritional supplement and is packaged in mylar package containing 10 capsules with an expiry date: 11/2020. Silver Bullet 10x was sold on eBay and website.Regular Mail or Fax: Download form http://www.fda.gov/MedWatch/getforms.htm2 or call: 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • 003-2019 Johnsonville, LLC Recalls Raw Ground Frozen Cheddar Cheese and Bacon Flavored Pork Patty Products Due to Possible Foreign Matter Contamination | En Español
  • 009-2019 Tyson Foods, Inc. Recalls Chicken Nugget Products due to Possible Foreign Matter Contamination
  • Pilgrim’s Pride Corporation, a Mt. Pleasant, Texas establishment, is recalling approximately 58,020 pounds of not-ready-to-eat (NRTE) breaded chicken products that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, not-ready-to-eat (NRTE) breaded chicken items were produced on Jan. 4, 2019. The following product is subject to recall: [View Labels (PDF only)]
    20-lb. boxes containing 8 clear bags of “UNCOOKED POPCORN STYLE CHICKEN BREAST CHUNK FRITTERS WITH RIB MEAT” with a “USE BY 10 01 2019” date and lot codes of 9004101012, 9004101013, 9004101014, 9004101015, 9004101016, 9004101017, 9004101018, 9004101019, 9004101020, 9004101021, 9004101022, 9004101000 and 9004101001.
    The products subject to recall bear establishment number “P-7091A” inside the USDA mark of inspection. These items were shipped to Publix Super Markets in Florida for deli food service use. 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 James Brown, Pilgrim’s Pride Corporation’s consumer relations, at (800) 321-1470. Media members with questions about the recall can contact Cameron Bruett, Pilgrim’s Pride Corporation’s media relations, at (970) 506-7801.
  • The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
    Recalled Product(s): CoaguChek XS PT Test Strips purchased from Terrific Care, LLC. or Medex Supply
    Lot Numbers: All lot numbers sold by Terrific Care LLC. or Medex Supply
    Manufacturing Dates: October 2017 to May 2018
    Distribution Dates: December 27, 2017 to December 15, 2018
    Devices Recalled in the U.S.: 759 boxes
    Device Use
    The CoaguChek XS PT Test Strips, manufactured by Roche Diagnostics, are used with the CoaguChek XS System to monitor patient response to warfarin (also known by the brand names Coumadin and Jantoven), a blood thinner prescribed to prevent and treat blood clots. The test strip is inserted into the CoaguChek XS System, and then a medical pricking needle (a lancet) is used to obtain blood from the patient’s finger (capillary) which is applied to the test strip. The meter reads the test strip, measures how long it takes the blood to clot, and provides the result based on a standardized calculation in the form of the International Normalized Ratio, or INR. Patients and physicians use the INR to determine if warfarin dosing is appropriate.Reason for Recall
    Terrific Care, LLC. / Medex Supply is recalling the Roche Diagnostics CoaguChek XS PT Test Strips due to inaccurate INR test results, when compared to laboratory results. The test strips may provide results that are higher than the actual INR. Because of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at an elevated risk of stroke, or those who had a recent blood clot.
    This recall is related to Roche Diagnostics’ recent U.S. recall of its CoaguChek XS PT Test Strips. However, the CoaguChek XS PT Test Strips distributed by Terrific Care LLC. /Medex Supply include catalog/REF numbers that were not included in the recent Roche recall because the test strips were not labeled or authorized for sale in the United States and were only distributed by Roche Diagnostics outside the U.S. Terrific Care, LLC. / Medex Supply purchased the Roche tests strips from an unknown source and imported and sold them in the United States.
    Use of recalled test strips may increase the risk of serious adverse health consequences, including, stroke, irreversible brain damage, and death.
    Who is affected?
    Patients that bought Roche CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply.
    Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:
    Mechanical heart valve
    Atrial fibrillation and high-risk CHA2DS2-VASc scores
    Recent thromboembolic events
    Health care providers, pharmacies and health care facilities that purchased CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply
    Distributors that purchased CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply
    What to Do
    On January 28, 2019, Terrific Care, LLC sent an Urgent Medical Device Recall Notification letter to customers. The letter asked customers to:
    Switch to new batches of CoaguChek XS PT Test Strips that are not affected by the recall. New batches of CoaguChek XS PT Test Strips may be obtained by contacting Roche Diagnostics Corporation at 1-800-428-4674.
    Patients should contact their health care provider to determine an alternative testing method while waiting for replacement CoaguChek XS PT Test Strips that are not affected.
    Immediately stop using all CoaguChek XS Test Strips purchased directly from Terrific Care, LLC. and Medex Supply.
    If you have product to return, send an email to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between the hours of 9:00 am – 5:00 pm Eastern Standard Time, Monday – Thursday.
    Include the “order ID” and insert “Recall” in the email subject line
    Complete and return the Recall Letter Response Form by email.
    For reimbursement, contact Terrific Care by phone at 888-433-2300 or by email at RMA@medexsupply.com
    Contact Information
    Customers who have questions or need additional information or support related to this recall should email to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between of 9:00 am – 5:00 pm Eastern Standard Time, Monday – Thursday.
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