FDA News

20 September

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Grace Imports, LLC Issues Allergy Alert of Undeclared Wheat in Kara Boondh, Kerala Mixture and Spicy Murukku

Posted by Asebey Law

Grace Imports, LLC., of Tucker, GA - September 20, 2024, is voluntarily recalling 250g bags of Kara Boondhi, Batch No. 2Al488 UPC 8 904123 53706, 300g bags of Kerala Mixture, Batch No. 2Al564 UPC 8 904123 500329 and 250g bag Spicy Murukku Batch No. 2Al504 UPC 8 904123 because these products contain Read More (external link)...

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20 September

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HP Hood LLC Recalls Select Units of 96 oz Refrigerated Lactaid Milk Due to Possible Almond Allergen

Posted by Asebey Law

HP Hood LLC is recalling five SKUs of 96 oz containers of LACTAID Milk because the product may contain trace amounts of almond, which is not listed on the label. People who have an allergy or severe sensitivity to almonds may run the risk of serious or life-threatening allergic reaction if they cons Read More (external link)...

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20 September

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Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

Posted by Asebey Law

paraPAC Plus P300 and P310 are emergency and transport portable ventilators. The patient outlet connector may be loose or detached, impacting ventilation. Read More (external link)...

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19 September

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Avole Inc. Issues Allergy Alert on Undeclared Fish in Bacalaitos Criollos Codfish Mix

Posted by Asebey Law

Avole Inc., located in San Sebastian, Puerto Rico is recalling 7-ounce bags of Bacalaitos Criollos Codfish Frying Mix because it may contain undeclared Fish (Pollock). People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consu Read More (external link)...

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19 September

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Dynarex Corporation Recalls Product Due to Possible Health Risk

Posted by Asebey Law

Dynarex Corporation is recalling 62 cases of item number 4875, Dynacare Baby Powder, Batch Number B 051, because it has the potential to be contaminated with asbestos. Asbestos is a naturally occurring mineral that is often found near talc, an ingredient in many cosmetic products. Asbestos, however, Read More (external link)...

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18 September

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123Herbals LLC (123Herbals.com) Issues Voluntary Nationwide Recall of Vail-Bon Jie Yang Wan Capsules Due to the Presence of Undeclared Dexamethasone and Chlorpheniramine

Posted by Asebey Law

Rosemead, CA, 123herbals is voluntarily recalling all lots of Vail-Bon Jie Yang Wan capsules to the consumer level. The product has been found to be tainted with the drug ingredients, dexamethasone and chlorpheniramine. Vail Bon Jie Yang Wan capsules is an unapproved new drug for which the safety an Read More (external link)...

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18 September

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Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing Defect that May Cause Tracheostomy Displacement or Decannulation

Posted by Asebey Law

Bivona tracheostomy tubes provide a secure airway in pediatric and adult patients. A manufacturing defect may lead to a tear in the tube’s flange. Read More (external link)...

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17 September

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Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

Posted by Asebey Law

September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be con Read More (external link)...

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17 September

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Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm

Posted by Asebey Law

Infusomat Space Infusion Systems deliver fluids, blood, and blood products. The occlusion alarm may sound when there is no occlusion, leading to delayed therapy. Read More (external link)...

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17 September

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Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture – FDA Safety Communication

Posted by Asebey Law

Read the FDA’s recommendations related to the Zimmer Biomet CPT Hip System and increased risk of thigh bone fracture. Read More (external link)...

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16 September

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Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

Posted by Asebey Law

Ivenix LVP infusion pump precisely controls the flow of fluids to a patient. A defect in pump administration sets may cause uncontrolled flow. Read More (external link)...

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13 September

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Investigation of Acute Non-viral Hepatitis Illnesses – “Real Water” Brand Alkaline Water (March 2021)

Posted by Asebey Law

The FDA, along with the CDC and the Southern Nevada Health District is investigating a number of reports of acute non-viral hepatitis in the state of Nevada. Read More (external link)...

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12 September

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FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur – Drug Safety Communication

Posted by Asebey Law

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury. Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella Stanley: Wood Ear Mushrooms – Dried Fungus (September 2020)

Posted by Asebey Law

The FDA, along with CDC and state and local partners, is investigating an ongoing multistate outbreak of Salmonella Stanley infections likely linked to wood ear mushrooms imported by Wismettac Asian Foods, Inc. of Santa Fe Springs, CA. Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella: Peanut Butter (May 2022)

Posted by Asebey Law

Outbreak Investigation of Salmonella in Peanut Butter Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella: Organic Basil (April 2024)

Posted by Asebey Law

The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Salmonella infections linked to Infinite Herbs-brand organic basil packed in 2.5-oz clamshell packaging and sold at Trader Joe’s stores. Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella Typhimurium: BrightFarms Packaged Salad Greens (July 2021)

Posted by Asebey Law

FDA is investigating a multistate outbreak of Salmonella Typhimurium infections linked to the consumption of BrightFarms packaged salad greens. Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella Thompson: Seafood (October 2021)

Posted by Asebey Law

The FDA, along with CDC and state and local partners, investigated a multistate outbreak of Salmonella Thompson infections linked to seafood manufactured or processed by Northeast Seafood Products, Inc. of Denver, CO. Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella Newport: Red Onions (July 2020)

Posted by Asebey Law

Outbreak Investigation of Salmonella Newport: Red Onions (July 2020) Read More (external link)...

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12 September

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Outbreak Investigation of Salmonella: Jule’s Cashew Brie (April 2021)

Posted by Asebey Law

The FDA, along with CDC and state and local partners are investigating a multistate outbreak of Salmonella Duisburg infections linked to the consumption of Jule’s Cashew Brie, a vegan, or plant-based cheese alternative. Read More (external link)...

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