Data showed the authorized dose of the drug is unlikely to be effective against the In the proportion of COVID-19 cases caused by the omicron BA.2 subvariant. However, the agency determined that the known and potential benefits of the vaccineįor the prevention of COVID-19 outweigh the known and potential risks for individualsĪn announcement that sotrovimab is no longer authorized to treat COVID-19 in any U.S. After conducting an updated analysis,Įvaluation, and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome warrants limiting the authorized Would otherwise not receive a COVID-19 vaccine. The vaccine is now only authorized for use in individuals ages 18 years and olderįor whom other authorized or approved COVID-19 vaccines are not accessible or clinicallyĪppropriate and in those ages 18 years and older who elect to receive it because they Restrictions of the authorized use of the Johnson & Johnson (Janssen) COVID-19 The imported lots were produced by a third-party manufacturer. retail stores and online.Ī recall of two lots of Mickey Mouse and Mandalorian Hand Sanitizer by Best Brand Consumers Products due to the presence of methanol and benzene, respectively. The affected products were in limited distribution at U.S. Suave 24-Hour Protection Aerosol Antiperspirant Fresh by Unilever due to the presence of slightly elevated levels of benzene, a human carcinogen. Of adverse events, including liver toxicity and death, and is investigating the distribution of these products in the U.S.Ī recall of all lots of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Mas Ajo Rey, and Ortiga Mas Ajo Rey Extra Forte. Products containing hidden drug ingredients include Artri Ajo King, Artri King, Ortiga FDA testing found the undeclared drug ingredients dexamethasone, diclofenac sodium, and methocarbamol. An FDA inspection observed conditions that could cause contamination or otherwiseĪ warning not to purchase or use certain Artri and Ortiga products due to potentially dangerous active ingredients not listed on the product label. While clinicians widely use these tests, none have yetīeen authorized, cleared, or approved by the FDA.Ī warning not to use products intended to be sterile produced by FarmaKeio Superior Custom Compounding due to a lack of sterility assurance. The FDA is aware of reports that patients and clinicians have made critical health care decisions based on results from these screening tests alone, without confirmatory testing. Such false results include reporting a genetic abnormality when the fetus does notĪctually have one. 18, 2021.Ī warning about the risk of false results with genetic noninvasive prenatal screening Nationwide to four wholesale customers from Dec. The recall includes 1,565 vials distributed No related adverse events have been reported. betweenĪ recall of one lot of idarubicin hydrochloride injection USP (5 mg/5 mL vials) by Teva Pharmaceuticals due to the presence of particulate matter identified as silica and iron oxide. Related adverse events have been reported. The recall does not pertain to the branded interchangeable biosimilar, Semglee. due to the potential for the label to be missing on some vials. and Puerto Rico from December 2019 toĪ recall of one batch of insulin glargine (insulin glargine-yfgn) injection (100 units/mL ) by Mylan Pharmaceuticals To wholesalers and distributors in the U.S. Recalled products were distributed nationwide 1, 2022.Ī recall of five lots of quinapril hydrochloride (Accupril) tablets by Pfizer due to excess levels of a nitrosamine impurity, N-nitroso-quinapril. The recall includesĦ29 devices distributed from April 1, 2016, to Jan. Adverse events reported include respiratoryįailure, pneumothorax, perforation, pneumonia, and pleural effusion. There have been 60 injuries and 23 patient deaths related to misplacement of nasogastricįeeding tubes while using the system since 2015. A class I recall of the Cortrak*2 Enteral Access System by Avanos Medical due to the risk of misplaced enteral tubes causing patient harm.
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