FDA Issues EUA for OTC COVID-19 Home Test
10/4/21 — The FDA issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test, which adds to the growing list of tests that can be used at home without a prescription. Read the FDA announcement.
CDC Health Advisory: COVID-19 Vaccination Recommended for Pregnant Women
9/29/21 — The CDC recommends urgent action to increase COVID-19 vaccination among people who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future. CDC strongly recommends COVID-19 vaccination either before or during pregnancy because the benefits of vaccination outweigh known or … Continue reading “CDC Health Advisory: COVID-19 Vaccination Recommended for Pregnant Women”
CDC Releases 2020 Data from the AR Lab Network
9/23/21 — CDC’s Antibiotic Resistance and Patient Safety Portal (AR&PSP) has released new 2020 data and resources from the AR Lab Network. CDC’s AR Lab Network supports nationwide lab capacity to rapidly detect antibiotic resistance and inform local responses to prevent spread and protect people. The update includes: “Carbapenem-resistant Acinetobacter baumannii (CRA): An urgent public health threat in United … Continue reading “CDC Releases 2020 Data from the AR Lab Network”
FDA Authorizes Booster Dose of Pfizer COVID-19 Vaccine
9/23/21 — The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in: individuals 65 years of age and older; individuals 18 through 64 years of age at high risk … Continue reading “FDA Authorizes Booster Dose of Pfizer COVID-19 Vaccine”
IntegraDose Recalls Cefazolin
9/23/21 — IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting from compounding in a newly installed … Continue reading “IntegraDose Recalls Cefazolin”
Advoque Safeguard Issues Respirator User Notice
9/17/21 — Advoque Safeguard issued a user notice identifying 6 very small lots of the model SG100 N95 Particulate Filtering Respirator (TC-84A-9284) that require additional sampling for pressure testing. Any individual or organization in possession of any ASG100 product in the 6 lots should isolate the product and contact Advoque Safeguard Quality Control (qc@advoquesafeguard.com). More information … Continue reading “Advoque Safeguard Issues Respirator User Notice”
CDC Health Advisory: Guidance for Clinicians Caring for Afghan Evacuees
9/20/21 — The CDC recommends that clinicians be on alert for cases of measles that meet the case definition, as well as other infectious diseases, including mumps, leishmaniasis, and malaria, among evacuees (including both Afghan nationals and U.S. citizens) from Afghanistan. Clinicians should immediately notify their local or state health department of any suspected cases of measles. Clinicians should also … Continue reading “CDC Health Advisory: Guidance for Clinicians Caring for Afghan Evacuees”
FDA Alert: Do Not Use Sterile Compounded Products from Greenpark Compounding Pharmacy
9/17/21 — The FDA is alerting patients and healthcare 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. FDA investigators recently inspected Greenpark Compounding Pharmacy’s facility during July and August 2021 and observed conditions which could … Continue reading “FDA Alert: Do Not Use Sterile Compounded Products from Greenpark Compounding Pharmacy”
COCA Now: New Resources Available for MIS-C
9/20/21 — The CDC has developed and tested new materials to support healthcare professionals (HCPs) in diagnosing and treating multisystem inflammatory syndrome in children (MIS-C). MIS-C is a rare, but serious complication associated with COVID-19 in children, adolescents, and young adults where multiple organ systems can become inflamed. Common symptoms may include ongoing fever, along … Continue reading “COCA Now: New Resources Available for MIS-C”
FDA Warns of Potential False Positives with some COVID-19 Test Kits
9/17/21 — The FDA is alerting clinical laboratory staff and healthcare 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 the PCR reaction mixture that may … Continue reading “FDA Warns of Potential False Positives with some COVID-19 Test Kits”