Image Español Many kids (and parents) who have seen Luke Skywalker battle Darth Vader with a light saber think lasers are cool. What they may not know is this: When operated unsafely, or without certain controls, the highly-concentrated light from lasers—even those in toys—can be dangerous, causing serious eye injuries and even blindness. And not…
Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency
Summary Company Announcement Date: April 29, 2021 FDA Publish Date: April 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Sub potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) Product Description: Product Description NP Thyroid (Thyroid Tablets, USP) Company Announcement Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the…
Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
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 Alaris Infusion Pump Module Model 8100 Front Bezel, purchased and/or installed by Pacific Medical Group (DBA Avante Health Solutions) Models: Alaris Model 8100 Serial Numbers: Please See…
Cáncer colorrectal: Lo que debe saber sobre las pruebas de detección
Image English La evidencia es clara – la detección de cáncer colorrectal puede salvarle la vida. En la actualidad, cada vez más personas optan por hacerse una prueba de detección de cáncer colorrectal. Como resultado, el número de personas mayores que padecen y mueren de cáncer colorrectal está disminuyendo de forma constante. La disminución de…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Jemperli (dostarlimab-gxly) for adults with mismatch repair deficient recurrent or advanced endometrial cancer and Zynlonta (loncastuximab tesirine-lpyl) for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
Podcast Welcome 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 have another update on two recent FDA cancer drug approvals. On April 22, 2021, FDA granted accelerated approval to dostarlimab-gxly (brand name…
Scentsational Soaps & Candles, Inc. Issues Voluntary Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
Summary Company Announcement Date: April 28, 2021 FDA Publish Date: April 28, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Company Name: Scentsational Soaps & Candles, Inc. Brand Name: Brand Name(s) Ulta Beauty Collection & SS Product Description: Product Description Scented Hand Sanitizer Company Announcement…
Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use
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 Products Precise PRO Rx US Carotid System Product and Lot numbers: Full List of Affected Devices Manufacturing Dates: October 2019 to August 2020 Distribution Dates: December 6, 2019…
FDA D.I.S.C.O. Burst Edition: Xalkori (crizotinib) and Darzalex Faspro (daratumumab plus hyaluronidase)
Podcast Welcome to the DISCO, 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 January 14, 2021, the FDA approved crizotinib (brand name Xalkori)…
Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 Infusion Pump Module
Summary Company Announcement Date: April 19, 2021 FDA Publish Date: April 19, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potentially weakened plastic Company Name: Tenacore LLC Brand Name: Brand Name(s) Tenacore LLC Product Description: Product Description 2001 Tenacore Replacement CareFusion Alaris 8100 bezels Company Announcement On February 24th, 2021, Tenacore LLC…
Infant Formula: Safety Do’s and Dont’s
[embedded content] Español The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them. Don’t Make Homemade Formula The FDA advises parents and caregivers to not make or feed homemade infant formula to infants. Homemade infant formula recipes…