Image English ¡Hombres, tengan cuidado! Los productos que se comercializan erróneamente como “suplementos nutricionales” o “dietéticos” que prometen mejorar el rendimiento sexual o aumentar la potencia sexual podrían contener fármacos ocultos u otros ingredientes no declarados y pueden poner en peligro su salud. Hasta ahora, las pruebas de laboratorio de la FDA han determinado que…
Tenga cuidado con las falsas promesas de las supuestas curas para el Alzheimer
[embedded content] English Seguramente usted conoce a una persona que padece la enfermedad de Alzheimer o una demencia relacionada a la misma y que incluye la pérdida de la memoria. Esto se debe en parte al hecho de que, a medida que crece la población de edad avanzada, aumenta también la cantidad de personas afectadas…
Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine – Letter to Clinical Laboratory Staff and Health Care Providers
December 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false reactivity, or “false-positive”, Rapid Plasma Reagin (RPR; non-treponemal) test results, when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit, can occur in some people who received a COVID-19 vaccine. Based on…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On December 2, 2021, the FDA approved rituximab (brand name…
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing Dates: December 2011 to Present Distribution Dates: March…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On November 29, 2021, the FDA approved pafolacianine (brand name…
Efficient Laboratories, Inc. Expands Voluntary Nationwide Recall to Consumers to Include Twelve Additional Lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM Sold in 2019 Due to Microbial Contamination Concerns
Summary Company Announcement Date: December 10, 2021 FDA Publish Date: December 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Efficient Laboratories, Inc Brand Name: Brand Name(s) Rompe Pecho Product Description: Product Description Liquid Cold & Flu symptom relief Company Announcement FOR IMMEDIATE RELEASE – 12/09/2021 – Miami, Florida….
Dermal Filler Do’s and Don’ts for Wrinkles, Lips and More
Image The FDA has issued a safety communication warning people to not use needle-free devices, such as hyaluron pens, for injection of hyaluronic acid or other lip and facial fillers. People are seeking treatments to smooth smile lines and crow’s feet and plump up their lips, cheeks, and hands. Injecting dermal fillers into the face…
Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency
Summary Company Announcement Date: December 07, 2021 FDA Publish Date: December 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Teligent Pharma, Inc. Product Description: Product Description Lidocaine HCl Topical Solution USP 4%, 50ml Company Announcement FOR IMMEDIATE RELEASE –07 December 2021…
Caution: Bodybuilding Products Can Be Risky
Español Your buddy at the gym can’t say enough about the bodybuilding products he’s been taking to help build muscle mass and strength. You wonder, are they all safe to use? According to CDR Mark S. Miller, Pharm. D., a regulatory review officer at the U.S. Food and Drug Administration (FDA), bodybuilding products that contain…