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 Name: Iso-Gard Filter S Product Models: See recall database entries Distribution Dates: September 1, 2020 to July 5, 2022 Devices Recalled in the U.S.: 60,500 Date…
Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication
Date issued: 11/3/2022 The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head…
Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol
Summary Company Announcement Date: November 05, 2022 FDA Publish Date: November 07, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Adam’s Polishes, LLC Brand Name: Brand Name(s) Adam’s Polishes Product Description: Product Description Hand sanitizer Company Announcement FOR IMMEDIATE RELEASE November 10th, 2022 – Thornton, Colorado, Adam’s Polishes,…
Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding
Image Español The next time you reach for a nonprescription drug to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin. Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion or upset stomach can cause stomach or intestinal bleeding, especially in some people,…
Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter
Summary Company Announcement Date: November 03, 2022 FDA Publish Date: November 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Filter may split or detach during use Company Name: Teleflex Incorporated Brand Name: Brand Name(s) Gibeck® and Iso-Gard® Product Description: Product Description Bacterial and viral filters Company Announcement WAYNE, Pa., Nov. 03,…
Se necesita una receta médica para adquirir lentes de contacto cosméticos y “de colores”
Image English ¿A poco no sería genial tener unos ojos de vampiro como los de la película Twilight para Halloween? ¿Y unos de color violeta intenso que combinen con su suéter morado? ¿Y qué le parecería tener el logotipo de su equipo deportivo favorito en los ojos sólo por diversión? Usted puede adoptar todos estos…
Insulet Issued Voluntary Medical Device Correction for Omnipod DASH® Personal Diabetes Manager on October 17, 2022
Summary Company Announcement Date: November 04, 2022 FDA Publish Date: November 05, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Battery issue: battery swelling, leakage, and in rare cases, extreme overheating, which has resulted in reports of fire. Company Name: Insulet Corporation Brand Name: Brand Name(s) Insulet Corporation Omnipod DASH Product Description:…
El uso seguro de los cosméticos para los ojos
Image English Ya sea que se maquille todos los días, para una ocasión especial o para una actuación, es importante tener especial cuidado alrededor de los ojos. La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) regula todos los cosméticos comercializados en los Estados Unidos, incluyendo los rímeles, las…
FDA D.I.S.C.O. Burst Edition: FDA approval of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options
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 another quick update on two recent FDA cancer drug approvals. On September 21, 2022, the FDA granted accelerated approval to…
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity
Summary Company Announcement Date: October 24, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo Pharma USA, Inc. Product Description: Product Description Quinapril and Hydrochlorothiazide Tablets…