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Archives

TruLaw FDA Warning Image

On July 28, 2023, Lupin Pharmaceuticals Inc., of Baltimore, Maryland, announced that it had voluntarily recalled two lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the consumer level. Officials noted that test results for […]

Aug 9, 2023 By TruLaw

FDA warns – 2 lots of Tydemy oral contraceptive tablets recalled due to potentially reduced effectiveness

TruLaw FDA Warning Image

Milford, New York-based Coopertown Cheese Company has announced a recall of 1400 pounds of cheese under multiple labels because the products may contain traces of the organism Listeria monocytogenes. Though healthy people infected with Listeria may only experience short-lived symptoms like “high fever, severe headache, […]

Aug 9, 2023 By TruLaw

FDA warns – 1400 pounds of Jersey Girl, Toma Celena, Abbie cheese products recalled due to risk of Listeria contamination

TruLaw FDA Warning Image

San Diego, California-based ONO LLC has voluntarily recalled a single lot of its 2.75-ounce packages of ONO Vegan Blueberry Muffin Protein Overnight Oats because the product may contain milk. Not only is milk not listed on the packaging’s ingredient statement, inclusion of the allergen directly […]

Aug 7, 2023 By TruLaw

FDA warns – ONO Vegan Blueberry Muffin Protein Overnight Oats recalled due to undeclared milk

TruLaw FDA Warning Image

GE HealthCare’s recall of its TruSignal SpO2 sensors has been identified as Class I, the most serious type, because use of the product may lead to serious injuries or death, according to the FDA. Placed on the skin, TruSignal sensors are indicated to continuously monitor […]

Aug 4, 2023 By TruLaw

FDA alerts to Class I recall of TruSignal SpO2 Sensors for risk of reduced defibrillation energy, exposure to unintended voltage, inaccurate readings

TruLaw FDA Warning Image

According to the FDA, Cava Foods, Inc. has voluntarily recalled a single lot of its CAVA Spicy Hummus because the product may contain sesame, an allergen not listed on the packaging’s ingredient statement. Individuals with an allergy or sensitivity to sesame could suffer a major […]

Aug 3, 2023 By TruLaw

FDA warns – Cava Spicy Hummus recalled due to mislabeling, undeclared sesame

TruLaw FDA Warning Image

A voluntary recall of all Impella Left Sided Blood Pumps by Abiomed has been labeled Class I, the most serious type, after the FDA determined that use of the product may result in serious injuries or death. Designed to temporarily support the pumping chambers of […]

Aug 2, 2023 By TruLaw

FDA alerts to Class I recall of Impella Left Sided Blood Pumps due to inadequate Instructions for Use, potential defect

TruLaw FDA Warning Image

According to the FDA, Dreyer’s Grand Ice Cream, Inc. has voluntarily recalled two batches of its 6-count packages of Outshine No Sugar Added Strawberry Fruit Bars because the products may contain trace levels of undeclared milk. The issue presents a particular risk to individuals with […]

Aug 1, 2023 By TruLaw

FDA warns – Outshine No Sugar Added Strawberry Fruit Bars recalled due to undeclared milk

TruLaw FDA Warning Image

Abbott has announced a Class I recall of its Amplatzer Steerable Delivery Sheath because patients who undergo procedures using this device face an increased risk for air bubbles (air emboli). The FDA identified the recall as Class I, the most serious type, because the device […]

Jul 31, 2023 By TruLaw

FDA alerts to Class I recall of Abbott Amplatzer Steerable Delivery Sheath due to increased risk of air embolism

TruLaw FDA Warning Image

According to the FDA, a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit, produced by Braga Fresh, has been voluntarily recalled because the product may contain undeclared milk and egg. Soledad, California-based Braga Fresh initiated the recall on […]

Jul 28, 2023 By TruLaw

FDA warns – 12-ounce bags of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit recalled due to undeclared allergens

TruLaw FDA Warning Image

The FDA is alerting consumers to the dangers of ultrasound medical devices manufactured by RoyalVibe Health, CellQuicken, and Well-Being Reality, all of which have not been reviewed for safety and effectiveness. The announcement, posted July 17, 2023, clarifies that because the FDA has not cleared […]

Jul 27, 2023 By TruLaw

FDA warns against use of unapproved RoyalVibe Health, CellQuicken, or Well-Being Reality ultrasound medical devices

TruLaw FDA Warning Image

Heinen’s, based in Warrensville Heights, Ohio, has announced a voluntarily recall of its Heinen’s-branded Fresh Ground Cashew Butter because it may contain peanuts or almonds, two allergens not declared in the product’s ingredient statement. The inadequate labeling presents a risk to consumers with an allergy […]

Jul 26, 2023 By TruLaw

FDA Warns – Heinen’s Fresh Ground Cashew Butter recalled due to undeclared peanuts, almonds

TruLaw FDA Warning Image

According to the FDA, Ziyad Brothers Importing has recalled its 35.2 fluid ounce packages of Ziyad Brand Jameed Soup Starter because the product’s ingredient list does not clearly declare the presence of milk, a major allergen. The inadequate labeling presents a particular risk to consumers […]

Jul 25, 2023 By TruLaw

FDA Warns – Packages of Ziyad Brand Jameed Soup Starter recalled due to undeclared milk

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