DeECO

FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry

By DeECO / March 9, 2023 / Comments Off on FDA Calls for Enhanced Safety Measures in Letter to Powdered Infant Formula Industry

Original Post Constituent Update March 8, 2023 Today, the U.S. Food and Drug Administration sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection…

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Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers

By DeECO / March 8, 2023 / Comments Off on Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers

Original Post March 7, 2023 The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs)…

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Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

By DeECO / March 6, 2023 / Comments Off on Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

Original Post Summary Company Announcement Date: March 03, 2023 FDA Publish Date: March 03, 2023 Product Type: Drugs Reason for Announcement: Non-sterility Company Name: Pharmedica USA LLC Brand Name: Purely Soothing Product Description: 15% MSM Drops Company Announcement Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops…

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Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

By DeECO / March 2, 2023 / Comments Off on Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments

Original Post While we remain vigilant to protect our families and communities from the spread of COVID-19, some might be tempted to buy or use questionable products that claim to help diagnose, treat, cure and even prevent coronavirus disease. Some people and companies are trying to profit from this disease by selling unproven and illegally…

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FDA Takes Action to Restrict Unlawful Import of Xylazine

By DeECO / March 1, 2023 / Comments Off on FDA Takes Action to Restrict Unlawful Import of Xylazine

Original Post For Immediate Release: February 28, 2023 Today, the U.S. Food and Drug Administration announced that it has taken action to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country to address a growing public health concern. The chemical xylazine has increasingly been found in illicit drugs…

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FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

By DeECO / February 28, 2023 / Comments Off on FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19 Viruses

Original Post For Immediate Release: February 24, 2023 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test…

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nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

By DeECO / February 23, 2023 / Comments Off on nanoMaterials Discovery Corporation Issues Voluntary Nationwide Recall of its Alcohol Antiseptic 80% Alcohol Solution

Original Post Summary Company Announcement Date: February 14, 2023FDA Publish Date: February 21, 2023 Product Type: Drugs Reason for Announcement: Due to presence of methanol Company Name: nanoMaterials Discovery Corporation Brand Name: nanoMaterials Discovery Corporation Product Description: Hand Sanitizer Company Announcement FOR IMMEDIATE RELEASE – February 14, 2023 – Seattle, Washington, nanoMaterials Discovery Corporation is…

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Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health Risk

By DeECO / February 22, 2023 / Comments Off on Reckitt Recalls Two Batches of Prosobee 12.9 oz Simply Plant Based Infant Formula Because of Possible Health Risk

Original Post Summary Company Announcement Date: February 20, 2023 FDA Publish Date: February 20, 2023 Product Type: Food & BeveragesInfant Formula & FoodsFoodborne Illness Reason for Announcement: Potential Cronobacter sakazakii contamination Company Name: Reckitt Brand Name: Enfamil ProSobee Product Description: Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers Company Announcement ‘The company has…

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FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

By DeECO / February 21, 2023 / Comments Off on FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

Original Post For Immediate Release: February 16, 2023 Statement From: Robert M. Califf, M.D., MACCCommissioner of Food and Drugs – Food and Drug Administration Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and…

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Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product

By DeECO / February 13, 2023 / Comments Off on Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product

Original Post FDA is warning health care professionals and pharmacies to avoid using Hospira’s unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population.   This product alone may produce daily aluminum exposures of up to twice the FDA-recommended limit for parenteral nutrition, with additional…

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