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From fda.gov

Outbreak Investigation

1 1

FDA’s investigation and sample analysis are ongoing.

#fda #usda #foodsafety #foodrecalls

20h ago

From fda.gov

FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review

1 6

FDA is proposing to end the use of oral phenylephrine for the temporary relief of nasal congestion because the agency determined it is not effective.

on Nov 8

From fda.gov

Niitakaya USA Inc. Issues Allergy Alert on Undeclared Allergen of Fish (Bonito) in #3700 Shiso Katsuo Ninniku/#3701 Miso Katsuo Ninniku

1 1

Niitakaya USA Inc. of Montebello, CA, is recalling All Best By dates of its 5.2 ounce (147 gram) packages of #3700 Shiso Katsuo Ninniku /#3701 Miso Katsuo Ninniku because they may contain undeclared Allergen of Fish (Bonito). People who have allergies to fish run the risk of serious or life-threaten

#fda #recall

on Sep 5

From fda.gov

Gilster - Mary Lee Corp. Issues a Recall for Undeclared Egg Allergen in Bowl & Basket Onion Soup Mix

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Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling two lots of Bowl & Basket Onion Soup Mix, UPC 41190-08394 at the consumer level because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or lif

on Thu, 1AM

From fda.gov

Micro-X Ltd. - 692084 - 09/10/2024

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CGMP/QSR/Medical Devices/Adulterated

on Mon, 11PM

From fda.gov

CIBUS Fresh, is Recalling CIBUS Fresh Products Containing Glenview Farms Spreadable Brie, 2/3lb Due to Supplier Notification of a Possible Listeria Monocytogenes

0 1

Use or consumption of products contaminated with Listeria monocytogenes 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 he

on Sat, 1AM

From fda.gov

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to address impact of IV fluid shortages following hurricane destruction and resolve manufacturing shortfalls

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Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage

on Fri, 12PM

From fda.gov

Hurricane Helene: Baxter's manufacturing recovery in North Carolina

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Information and updates on CDER-regulated drug and biologic products

on Fri, 12PM

From fda.gov

Babcock Dairy Recalls Orange Custard Chocolate Chip and Chocolate Peanut Butter Due to Undeclared Egg

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Babcock Dairy of Madison, Wisconsin, is voluntarily recalling approximately 41 cases of Orange Custard Chocolate Chip ice cream that may be labeled as Chocolate Peanut Butter. People who have an allergy or severe sensitivity to eggs or yellow #5 run the risk of serious or life-threatening allergic r

on Nov 8

From fda.gov

VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

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Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. VitalityXtra was found to be tainted with sildenafil, an ingredient in FDA approved products for

on Nov 7

From fda.gov

Savencia Cheese USA Announces an Expanded Voluntary Recall of Select Soft Ripened Cheeses

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Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility 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

on Nov 6

From fda.gov

Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

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Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Casules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA appro

on Nov 6

From fda.gov

FDA is warning patients and health care professionals not to use drugs

0 1

FDA is warning patients and health care professionals not to use drugs compounded and distributed by Fullerton Wellness LLC, Ontario, Calif., and distributed to patients by medical offices and clinics.

on Nov 5

From fda.gov

Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses

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Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility 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

on Nov 5

From fda.gov

HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk

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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 suc

on Nov 3

From fda.gov

Elevation Foods Issues Recall Due to Undeclared Soy in Hannaford Seafood Salad

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Danvers, Massachusetts. R. Walters LLC dba Elevation Foods is recalling 1,668 units of mislabeled Hannaford Seafood Salad 12oz because it contains an undeclared Soy allergen. Consumers with an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they

on Nov 1

From fda.gov

Drug Shortages | FDA

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The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that products that emit radiation.

on Oct 31

From fda.gov

FDA Roundup: October 29, 2024

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FDA Roundup

on Oct 31

From fda.gov

Atwater’s Issues Allergy Alert on Undeclared Tree Nuts in “Spider Web Tart”

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Atwater’s of Baltimore, MD, is recalling its clam shell packages of spider web tarts sold 10/19/24 and 10/20/24 because they contain undeclared almond flour. People who have allergies to tree nuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

on Oct 29

From fda.gov

Dynarex Corporation Expands Recall to Include Additional Products Due to Possible Health Risk

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Dynarex Corporation is expanding the recall initiated on September 19, 2024, to include an additional 373 cases of item number 4875, Dynacare Baby Powder, 14 oz., as well as 647 cases of item number 4874, Dynacare Baby Powder, 4 oz., because they have the potential to be contaminated with asbestos.

on Oct 29

From fda.gov

Acme Smoked Fish Corporation Recalls Kirkland Signature Smoked Salmon Due to Listeria Monocytogenes Contamination

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Acme Smoked Fish Corporation is issuing a recall of 111 cases of Kirkland Signature Smoked Salmon in twin 12oz package, UPC 0 96619 25697 6, Lot# 8512801270, Best-by-Date 11/13/2024 due to laboratory testing confirming Listeria monocytogenes on October 21, 2024. Listeria monocytogenes, an organism w

on Oct 28

From fda.gov

Fresh Express is Voluntarily Recalling a Limited Number of Gourmet Café Chicken Caesar Salad Bowls

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Fresh Express is voluntarily recalling a limited number of Gourmet Café Chicken Caesar Salad Bowls due to the inclusion of recalled chicken items from BrucePac, an outside ingredient supplier. The BrucePac recall is due to possible Listeria monocytogenes contamination. The fresh vegetable components

on Oct 28

From fda.gov

Recalls, Market Withdrawals, & Safety Alerts

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FDA and industry press releases regarding product recalls

on Oct 27

From fda.gov

Grand Central Bakery Issues Allergy Alert on Undeclared Egg in U-Bake Pie Crust, U-Bake Apple Pie, U-Bake Marionberry Pie, and U-Bake Chicken Pot Pie

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October 25, 2024, Grand Central Bakery Portland, OR and Seattle, WA is recalling U- Bake frozen pie products and frozen pie dough because they may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they co

on Oct 27

From fda.gov

Sprouts Farmers Market has Voluntarily Recalled Select Lots of Our Chicken Street Taco Kits Supplied by Fresh Creative Foods, Due to Possible Listeria Monocytogenes Contamination

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Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Sprouts Farmers Market has voluntarily recalled select lots of our Chicken Street Taco kits supplied by Fresh Creative Foods on 10/11/2024, due to possible Listeria monocytogenes contamination.

on Oct 25

From fda.gov

TreeHouse Foods Announces Expansion of Voluntary Recall to Include All Waffle and Pancake Products Due to the Potential for Listeria monocytogenes Contamination

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TreeHouse Foods, Inc. (NYSE: THS) is expanding its voluntary recall to include all products manufactured at one facility and still within their shelf-life. The recall is expanded to include frozen toaster waffle, Belgian waffle and pancake products, due to the potential to be contaminated with List

on Oct 23

From fda.gov

Outbreak Investigation

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Linked to McDonald’s Quarter Pounders served in certain states. Investigators are working to confirm the source of the outbreak.

on Oct 23

From fda.gov

TreeHouse Foods Announces Voluntary Recall of Certain Waffle Products Due to the Potential for Listeria monocytogenes Contamination

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OAK BROOK, Ill., Oct. 18, 2024 /PRNewswire/ -- TreeHouse Foods, Inc. (NYSE: THS) is voluntarily recalling certain frozen waffle products listed below due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism that can cause serious and sometimes fatal

on Oct 23

From fda.gov

November 20-21, 2024: Digital Health Advisory Committee Meeting

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November 20-21, 2024: Digital Health Advisory Committee Meeting Announcement

on Oct 23

From fda.gov

Reser’s Fine Foods Announces Voluntary Recall of Limited Number of Meal Kits Due to Recalled Chicken from Ingredient Supplier (BrucePac)

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Out of an abundance of caution, Reser’s Fine Foods is voluntarily recalling a limited number of meal kits due to the inclusion of recalled chicken from an outside ingredient supplier (BrucePac). The ingredient supplier (BrucePac) recall is due to possible Listeria monocytogenes contamination.

on Oct 23

From fda.gov

Con Yeager Spice Company Issues Allergy Alert on Undeclared Soy and Wheat in Trail Bologna Meat Processing Kits

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The Con Yeager Spice Company of Zelienople, PA, is recalling its TRAIL BOLOGNA MEAT PROCESSING KITS, because they may contain undeclared soy and wheat. People who have an allergy or severe sensitivity to soy and wheat run the risk of serious or life-threatening allergic reaction if this product is c

on Oct 22

From fda.gov

Enoki King Mushroom Farm Recalls Enoki Because of Possible Health Risk

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Enoki King Mushroom Farm of Ventura, CA is recalling lot 4877 of its 5.3-ounce (150g) packages of Enoki Mushroom (Product of USA) 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 o

on Oct 21

From fda.gov

Tipical Latin Food, Corp. Issues Allergy Alert on Undeclared Wheat in Cachapa de Maiz

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TIPICAL LATIN FOOD CORP of Miami, FL is recalling Cachapa de Maiz sweet corn pancakes labeled under Los Andes Foods, because it may contain undeclared wheat. People who have an allergy or severe sensitivity to run the risk of serious or life-threatening allergic reaction if they consume these produc

on Oct 21

From fda.gov

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

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Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medt

on Oct 20

From fda.gov

Church Brothers Farms Recall Green Onions Due to Possible Health Risk

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Salinas, CA, October 18, 2024 (For Distribution) - Church Brothers, LLC (“Church Brothers Farms”) is voluntarily recalling 1271 cases of green onions because of the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, fra

on Oct 20

From fda.gov

Albertsons Companies Voluntarily Recalls 12 ReadyMeals and Store-Made Deli Items Containing a Recalled Chicken Ingredient Supplied by Fresh Creative Foods Due to Possible Listeria monocytogenes Contamination

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Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Albertsons Companies has voluntarily recalled 12 types of ReadyMeals and store-made deli items, supplied by Fresh Creative Foods, due to possible Listeria monocytogenes contamination.

on Oct 20

From fda.gov

Dakota Tom’s Sandwiches Recalls Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler Because of Possible Health Risk

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Dakota Tom’s Sandwiches Corsica, SD is voluntarily recalling our Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler due to the burger patty being included in a recall from an outside supplier (BrucePac). The ingredient supplier (BrucePac) recall is due to possible Listeria monocytogenes con

on Oct 19

From fda.gov

Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles

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Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch.

on Oct 18

From fda.gov

C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol

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10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot b

on Oct 18

From fda.gov

Youngstown Grape Distributors Inc. Recalls Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields Because of Possible Health Risk

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Youngstown Grape Distributors Inc., a co-manufacturer for Happy Moose Juice, is voluntarily recalling Happy Moose Tropical Roots Juice (Lot# H240903-E BEST BY 12/02/2024) and Happy Moose Strawberry Fields (Lot# H240903-H, BEST BY 12/02/2024) because a portion of the production made did not complete

on Oct 8

From fda.gov

Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

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The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy.

on Oct 8

From fda.gov

Jacks and the Green Sprouts Recalls Alfalfa and Alfalfa Onion Sprouts Because of Possible Health Risk

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Jack and the Green Sprouts, Inc. of River Falls, WI is recalling its 5 ounce packages of Alfalfa and Alfalfa Onion sprouts 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 el

on Oct 6

From fda.gov

CDER Statement

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FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

on Oct 5

From fda.gov

Tainted Arthritis and Pain Products

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Certain products promoted for arthritis and pain management have been found to contain hidden ingredients and may pose a significant health risk. Learn more.

on Oct 5

From fda.gov

Lunds & Byerlys Voluntarily Recalls L&B Lone Star Dip Due to Potential Mold

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Edina, Minn. (October 4, 2024) – Lunds & Byerlys is voluntarily recalling approximately 500 containers of L&B Lone Star Dip because of potential mold growth contamination. The recalled product was sold at Lunds & Byerlys stores throughout the Twin Cities and surrounding area.

on Oct 5

From fda.gov

CDER Statement 11142017

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The U.S. Food and Drug Administration is actively working with drug manufacturers to address critical shortages of IV fluids aggravated by Hurricane Maria’s impact on Puerto Rican drug manufacturing facilities.

on Oct 4

From fda.gov

Livestock Nutrition Center - 643701 - 12/15/2022

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CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

on Sep 30

From fda.gov

FDA Roundup: May 17, 2024

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FDA Roundup: May 17, 2024

on Sep 29

From fda.gov

FDA Approves Drug with New Mechanism of Action for Treatment of Schizophrenia

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FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.

on Sep 27