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Food & drugs

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

27-04-2020

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using...

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Surgical Mask and Gown Conservation Strategies - Letter to Health Care Providers

27-04-2020

The FDA recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to health care organization during the Coronavirus Disease 2019...

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UPDATE: Potential Risks with Liquid-filled Intragastric Balloons - Letter to Health Care Providers

27-04-2020

An update on the potential risks of over-inflation (spontaneous hyperinflation), acute pancreatitis, and deaths in patients with Orbera and ReShape liquid-filled intragastric balloons used for weight loss in adult patients with obesity.

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Medical Glove Conservation Strategies: Letter to Health Care Providers

27-04-2020

FDA recognizes that the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak.

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CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets

27-04-2020

CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of...

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Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Se

24-04-2020

FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease.

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Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

23-04-2020

QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using...

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Royal International Trading Inc Issues Alert On Undeclared Sulfites In “Tayni Boctoka Dry Fruits Mix Compot Apple”

22-04-2020

ROYAL INTERNATIONAL TRADING Inc of Brooklyn, NY is recalling its 500g (17.63oz) packages of "TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE" because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of...

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Royal International Trading Inc Issues Alert On Undeclared Sulfites In “Tayni Boctoka Dry Fruits Mix Compot Apple”

22-04-2020

ROYAL INTERNATIONAL TRADING Inc of Brooklyn, NY is recalling its 500g (17.63oz) packages of "TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE" because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of...

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Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number

21-04-2020

Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into storebrand or retail...

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Allergy Alert Issued by Buckhead Meat and Seafood of Houston, Inc. for Undeclared Wheat, Soy, Milk, Fish and Eggs in Frozen Flo

21-04-2020

Buckhead Meat and Seafood of Houston, Inc., a Sysco Company, is voluntarily recalling a small quantity of frozen Flounder Stuffed with Seafood because its labeling inadvertently did not identify the following allergens in the product: wheat, soy,...

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Ocean Spray Cranberries, Inc Recalls Single Production Lot of 5.5 Oz Cans of Pink Lite Cranberry Juice Drink Because of Undecla

21-04-2020

Ocean Spray Cranberries, Inc. is recalling a single production lot of 5.5oz cans of Pink Lite Cranberry Juice Drink (listed below) because it may contain undeclared sulfites, which were erroneously added by a contract manufacturer.

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Food & drugs

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

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