FDA/USDA~February/March ~2019~ Alerts & Safety


  • Washington Beef, LLC, a Toppenish, Wash. establishment, is recalling approximately 30,260 pounds of ground beef chubs products that may be contaminated with extraneous materials, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The ground beef chubs were produced on Dec. 27, 2018, and include a “Use or Freeze by” date of 01/20/19. The following products are subject to recall: [View Labels (PDF only)]
    · See attached spreadsheet here.
    The products subject to recall bear establishment number “EST. 235” inside the USDA mark of inspection. These items were shipped nationwide.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 Jay Theiler, Vice President of Marketing at Washington Beef, at (855) 472-6455. Media with questions about the recall can contact, Jayne Davis, Director of Corporate and Media Affairs at Washington Beef, at (855) 472-6455.
  • Bellisio Foods, a Jackson, Ohio establishment, is recalling approximately 173,376 pounds of frozen pork entrée products that may be contaminated with extraneous materials, specifically pieces of glass or hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
    The frozen, not ready-to-eat (NRTE) boneless pork rib patties were produced on various dates from Dec. 7, 2018 to Feb. 15, 2019. The following products are subject to recall: [View Labels (PDF only)]
    14-oz. black cardboard box packages containing “BOSTON MARKET Home Style Meals BONELESS PORK RIB SHAPED PATTY WITH BBQ SAUCE & MASHED POTATOES” with “BEST BY:” dates of 12/07/2019 lot code 8341, 01/04/2020 lot code 9004, 01/24/2020 lot code 9024, or 02/15/2020 lot code 9046, represented on the label.
    The products subject to recall bear establishment number “EST. 18297” on the end carton flap of the package. These items were shipped to a Department of Defense facility in Tucson, Ariz. and retail locations nationwide.
    Consumers with questions about the recall can contact Krista Cummings, Consumer Affairs Supervisor, Bellisio Foods at (855) 871-9977. Members of the media with questions about the recall can contact Tom Lindell, Public Relations, at (612) 305-6419.
    The problem was discovered when the establishment received consumer complaints of glass or hard plastic extraneous material in the rib shaped patty. FSIS was notified on Feb. 22, 2019.
    There have been no confirmed reports of adverse reactions or injuries due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
  • MedWatch Safety Alert: FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer intended for: Oncology, Radiology, Health Professional was just added to the FDA Medical Device Safety, Safety Communications web page.You can read the complete MedWatch Safety Alert that includes recommendations at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm631885.htm
  • Russ Davis Wholesale – Crazy-Fresh, an Eagan, Minn. establishment, is recalling approximately 702 pounds of chicken Caesar salad 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 and anchovies, known allergens, which are not declared on the product label.
    The chicken Caesar salad items were produced from Feb. 11, 2019 through Feb. 22, 2019. The following products are subject to recall: [View Labels (PDF only)]
    10-oz. black plastic bowl with a clear plastic lid containing “CRAZY FRESH Chicken Caesar Salad” and “Use By” dates of 02/15/2019 through 02/26/2019 represented on the label.
    10-oz. black plastic bowl with a clear plastic lid containing “JERRY’S the kitchen CHICKEN CAESAR SALAD” and “SELL BY” dates of 02/15/2019 through 02/26/2019 represented on the label.
    The products subject to recall bear establishment number “P-45204” inside the USDA mark of inspection. These items were shipped to retail locations in Iowa, Mich., Minn., Mont., Neb., N.D., S.D., Wis., and Wyo.
    The problem was discovered on February 24, 2019, when FSIS was notified that the establishment discovered the misbranding of product while performing a label review.
    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. Members of the media with questions about the recall can contact Amy Rotenberg, Russ Davis Wholesale – Crazy-Fresh, at (202) 756-1028. Consumers with questions about the recall can contact Russ Davis Wholesale – Crazy-Fresh Customer Service at (877) 433-2173.
  • A new MedWatch Safety Alert: Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients intended for: Patient, Health Professional, Pharmacy, Rheumatology was just added to the FDA MedWatch Webpage. You can read the complete MedWatch Safety Alert that includes recommendations at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM632016
  • Updates• 019-2019, Fulton Seafood Inc. Recalls Siluriformes Products Produced Without Benefit of Inspection (Feb 22, 2019)
  • MedWatch Safety Alert Recall: GoLean Detox Capsules by GoLean Detox USA: Recall – Due to Presence of Undeclared Sibutramine and Phenolphthalein was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/Safety/Recalls/ucm632004.htm
  • 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.
    The problem was discovered, and FSIS was notified, on February 22, 2019 when the establishment received a complaint of extraneous material in a ham product that was produced for retail deli slicing.
    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.
  • Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have 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.
    The company shipped the recalled product to one retail distribution center. Although most of the product was retrieved before distribution to retail stores, some product shipped on February 17th may have reached select stores in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee and Virginia. So, in an abundance of caution, we are issuing this public announcement.
    To date, Southern Specialties has not been informed of any illnesses associated with this recall.
  • A new MedWatch Safety Alert recall: LIFEPAK15 by Physio-Control: Class I Recall – Due to Risk of Device “Lockup” (Freezing) was just added to the FDA Recalls webpage.You can read the complete recall alert at: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm632203.htm   Brand
    Product Description
    UPC
    Located in the white box on back of package in the lower right hand corner
    Best if Used By date
    Located in the white box on the front of the package in the right hand corner
    Lot codes on bag
    Located in the white box on the front of the package in the right hand corner
    Marketside
    Bagged Green Beans, 32oz. (2 LB) 907g
    681131457385
    MAR-9-2019
    83931-123 or 83939-124
    Marketside
    Bagged Green Beans, 12 oz. (340g)
    681131328869
    MAR-8-2019
    83928-628 or 83932-123
    Marketside
    Bagged Butternut Squash, 16oz. (1 LB) 454g
    681131122351
    MAR-6-2019
    83940-319 or 83940-139Consumers with questions regarding this recall may contact the company at 1-954-876-2453 or visit http://www.southernspecialties.com. We will return calls within 24 hours.
  • ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock™ and ChemoClave® Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device. The affected product lot was distributed nationwide to ICU Medical customers between August 2018 and February 2019. The affected lots are listed below:Item Number
    Description
    Lot Number
    CH3943
    Oncology Kit w/12″ Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm; Spiros™ w/Red Cap
    3846114, 3855564, 3902719, 3961122
    CH3944
    Oncology Kit w/12″ Ext Set w/Spiros™ w/Red Cap, Clamp, Graduated Adapter; ChemoClave™ Vented Vial Spike, 20mm; ChemoClave™ Vented Vial Spike, 13mm
    3846116, 3855565
    CH-70S
    ChemoClave® Vented Vial Spike, 20mm
    3866759, 3872252, 3910046, 3910627
    CH-80S
    ChemoClave® Vial Spike, 20mm
    3826647, 3826648, 3826844, 3827598
    3839689, 3839690, 3854000, 3854001
    3866761, 3873006, 3936065, 3952512
    CL-80S
    ChemoLock™ Vial Spike, 20mm
    3757712,3824204, 3824209, 3826652
    3828646, 3829557, 3836196, 3836811
    3853995, 3853997, 3866764, 3866766
    3872065, 3872072, 3872085, 3872093
    3872433, 3872444, 3910642, 3920773
    3932270, 3945868, 3946776
    CL-80S-10
    ChemoLock™ Vial Spike, 20mm, 10 units
    3820519, 3820522, 3839240, 3839241
    3844783, 3844784, 3854004, 3854005
    3910656, 3932907, 3946771, 3946772
    CL-80S-4
    ChemoLock™ Closed Vial Spike w/Skirt, 4 Units
    3820520, 3820521, 3844785
    CL-80S-5
    ChemoLock™ Closed Vial Spike w/Skirt, 5 Units
    3820516, 3820523, 3839238, 3839239
    3844781, 3844782, 3853998, 3853999
    3866769, 3866770, 3872090, 3910645
    3932908, 3932910, 3946770, 3951236
    Z7148
    ChemoClave® Vented Vial Spike, 20mm
    3872008, 3899761 ICU Medical is asking customers to discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility and return the affected product to Stericycle for credit. For instructions on returning product or additional assistance, call Stericycle at 1-888-871-7114 Monday through Friday, between the hours of 8 a.m. to 5 p.m. Eastern Time.
    Customers with questions regarding this recall can call ICU Medical at 1-877-946-7747, Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time.
  • Updates• 023-2019, McAllen Cold Storage, Ltd. Recalls Siluriformes Fish Products Produced Without Benefit Of Inspection (Feb 26, 2019)
  • Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.
    The recalled Joy Brand Chutneys and Pastes were distributed in NY, NJ,and CT in retail stores.The products comes in 8 oz,14 oz,16 oz, and 26 oz, 32 oz. clear glass jar packages and marked on the labels as follows:
    Product Name
    Batch Code
    Expiration Date
    Sizes
    Bar Code
    Ginger Paste
    0226
    02/26/2019
    8 oz./ 26 oz.
    68061760002/
    68061760001
    Ginger Paste
    411
    04/11/2019
    8 oz./ 26 oz.
    68061760002/
    68061760001
    Ginger Paste
    0706
    07/06/2019
    8 oz./ 26 oz.
    68061760002/
    68061760001
    Ginger Paste
    0731
    07/31/2019
    8 oz./ 26 oz.
    68061760002/
    68061760001
    Ginger Paste
    01029
    10/29/2019
    8 oz./ 26 oz.
    68061760002/
    68061760001
    Garlic Paste
    0227
    02/27/2019
    8 oz./ 26 oz.
    68061760004
    68061760003
    Garlic Paste
    0425
    04/25/2019
    8 oz./ 26 oz.
    68061760004
    68061760003
    Garlic Paste
    0709
    07/09/2019
    8 oz./ 26 oz.
    68061760004
    68061760003
    Garlic Paste
    0813
    08/13/2019
    8 oz./ 26 oz.
    68061760004
    68061760003
    Garlic Paste
    01106
    11/06/2019
    8 oz./ 26 oz.
    68061760004
    68061760003
    Gol-Gappa(pani puri)masala concentrates
    0712
    07/12/2019
    8 OZS
    68061760414
    Ginger/Garlic Mix
    0228
    02/28/2019
    8 oz./ 26 oz.
    68061760006
    68061760005
    Ginger/Garlic Mix
    0509
    05/09/2019
    8 oz./ 26 oz.
    68061760006
    68061760005
    Ginger/Garlic Mix
    01112
    11/12/2019
    8 oz./ 26 oz.
    68061760006
    68061760005
    Tamarind Concentrates
    0306
    03/06/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Tamarind Concentrates
    0314
    03/14/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Tamarind Concentrates
    0614
    06/14/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Tamarind Concentrates
    0717
    07/17/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Tamarind Concentrates
    01022
    10/22/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Tamarind Concentrates
    01211
    12/14/2019
    14 oz./ 32 oz.
    68061760020
    68061760021
    Dates And Tamarind Chutney
    0322
    03/22/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Dates And Tamarind Chutney
    0402
    04/02/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Dates And Tamarind Chutney
    0626
    06/26/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Dates And Tamarind Chutney
    01017
    10/17/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Dates And Tamarind Chutney
    01120
    11/20/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Dates And Tamarind Chutney
    0723
    07/23/2019
    8 OZS/16 OZS/32 OZS
    68061760437
    68061760438
    68061760022
    Idlee/Dosa Chutney
    0920
    09/20/2019
    8 OZS
    68061760420
    Green chilly Chutney
    0522
    05/22/2019
    8 OZS
    68061760412
    Green chilly Chutney
    0906
    09/06/2019
    8 OZS
    68061760412
    Bhel Chutney
    0601
    06/01/2019
    8 OZ
    68061760433
    Chat Chutney
    0103
    10/03/2019
    8 OZ
    68061760433
    Corriander Chutney
    0627
    06/27/2019
    8 OZ/26 OZS
    68061760402
    68061760401
    Corriander Chutney
    0822
    08/22/2019
    8 OZ/26 OZS
    68061760402
    68061760401
    Corriander Chutney
    01214
    12/14/2019
    8 OZ/26 OZS
    68061760402
    68061760401
    No illnesses or allergic reactions involving this product have been reported to date.
    The recall was initiated after a routine inspection by a United States of America Food and Drug Administration(FDA) Food Inspector, which revealed that the sulfites containing product was distributed in packages that did not declare their presence.
    Consumers who have purchased the Joy Brand Chutneys and Pastes 8 oz, 14 oz,16 oz, and 26 oz,32 oz. are urged to return them to the place of purchase for a full refund. Consumer who can not return to the place of business where they purchased the product can destroy the product and call us for a full refund. Consumer with questions may contact the company at 718-821-6050.we are open monday to friday from 10.00 a.m to 4 .00 p.m.
  • Updates• 022-2019, Sahlen Packing Company, Inc. Recalls Ready-To-Eat Deli Meat Products Due to Possible Foreign Matter Contamination (Feb 26, 2019)
    021-2019, Russ Davis Wholesale – Crazy-Fresh Recalls Chicken Products due to Misbranding and Undeclared Allergens (Feb 25, 2019)
  • Recall of Losartan Potassium and Valsartan Tablets

018-2019, TV Food LLC. Recalls Siluriformes Products Produced Without Benefit of Inspection (Feb 22, 2019)

 

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