Original Post Summary Company Announcement Date: March 10, 2023 FDA Publish Date: March 10, 2023 Product Type: Animal & Veterinary Reason for Announcement: Potential Elevated Ingredient Level Company Name: Nestle Purina PetCare Company Brand Name: Purina Product Description: Pro Plan Veterinary Diets EL Elemental (PPVD EL) prescription dry dog food Company Announcement Nestlé Purina PetCare…
Read MoreOriginal Post For Immediate Release: March 14, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination…
Read MoreOriginal Post Summary Company Announcement Date: March 10, 2023 FDA Publish Date: March 10, 2023 Product Type: Medical Devices Reason for Announcement: Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator Company Name: Baxter International Inc. Brand Name:…
Read MoreOriginal 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…
Read MoreOriginal 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)…
Read MoreOriginal 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…
Read MoreOriginal 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…
Read MoreOriginal 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…
Read MoreOriginal 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…
Read MoreOriginal 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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