DeECO

Microneedling Devices: Getting to the Point on Benefits, Risks, and Safety

By DeECO / September 23, 2021 / Comments Off on Microneedling Devices: Getting to the Point on Benefits, Risks, and Safety

Being pricked by tiny needles may sound like a strange way to make your skin look better, but that’s the concept behind a skin care technique called microneedling. People are using microneedling in a variety of ways from reducing scarring, to treating fine lines and wrinkles. It is important to be aware of the risks…

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FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy

By DeECO / September 20, 2021 / Comments Off on FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy

[9/17/2021] FDA is alerting patients and health care professionals not to use compounded products intended to be sterile, produced and distributed nationwide by Prescription Labs Inc. doing business as Greenpark Compounding Pharmacy, Houston, Texas, due to lack of sterility assurance. Administration of non-sterile products intended to be sterile may result in serious and potentially life-threatening infections…

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Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits – Letter to Clinical Laboratory Staff and Health Care Providers

By DeECO / September 20, 2021 / Comments Off on Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits – Letter to Clinical Laboratory Staff and Health Care Providers

September 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false-positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false-positive results may be related to current mixing parameters of…

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FDA MedWatch – FDA Issues Revised Policy on Face Masks and Respirators During COVID-19

By DeECO / September 16, 2021 / Comments Off on FDA MedWatch – FDA Issues Revised Policy on Face Masks and Respirators During COVID-19

U.S. Food and Drug Administration sent this bulletin at 09/15/2021 03:14 PM EDT If your email program has trouble displaying this email, view as a webpage. MedWatch – The FDA Safety Information and Adverse Event Reporting Program FDA Issues Revised Policy on Face Masks and Respirators During COVID-19 The FDA issued revised guidance: Enforcement Policy for Face Masks, Barrier…

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Updated Coronavirus Q&A From FDA

By DeECO / September 1, 2021 / Comments Off on Updated Coronavirus Q&A From FDA

U.S. Food and Drug Administration sent this bulletin at 09/01/2021 09:19 AM EDT Coronavirus Q&As for Consumers The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccines, medicines for COVID-19,…

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08/11/2021 – Your Updated Coronavirus Q&A From The FDA

By DeECO / August 11, 2021 / Comments Off on 08/11/2021 – Your Updated Coronavirus Q&A From The FDA

The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about vaccines. Q: Is an approval (or biologics license approval) different from an emergency use authorization? Does it change the availability of…

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Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements

By DeECO / August 10, 2021 / Comments Off on Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements

Summary Company Announcement Date: August 08, 2021 FDA Publish Date: August 08, 2021 Product Type: Food & Beverages Reason for Announcement: Products do not meet FDA requirements. Company Name: Able Groupe Brand Name: HiPP, Holle, Bioland, & Kendamil Product Description: Products labeled as infant formula Company Announcement Able Groupe announced today it is recalling certain…

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Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children

By DeECO / August 3, 2021 / Comments Off on Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children

Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek emergency medical…

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Updated Coronavirus Q&As for Consumers

By DeECO / July 21, 2021 / Comments Off on Updated Coronavirus Q&As for Consumers

Your Coronavirus Q&A From FDA U.S. Food and Drug Administration sent this bulletin at 07/21/2021 08:51 AM EDT Coronavirus Q&As for ConsumersThe FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about…

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Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene

By DeECO / July 20, 2021 / Comments Off on Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene

Summary Company Announcement Date: July 14, 2021, FDA Publish Date: July 14, 2021, Product Type: Drugs,  Reason for Announcement: Testing identified low levels of benzene, Company Name: Johnson & Johnson, Brand Name: Neutrogena, Aveeno, Product Description: Sunscreen Company Announcement Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO®…

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