[Posted 05/26/2023] AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of…
Drugs
Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Steve Green Recipient Title Owner Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas 4216 LBJ FreewayDallas, TX 75244United States [email protected] Issuing Office: Center for Tobacco Products United States WARNING LETTER May 18, 2023 Dear Mr. Green: The Center for Tobacco Products of…
SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination
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: Pilot COVID-19 At-Home Tests Product Codes: See Safety Communication Distribution Dates: August 2022 to March 2023 Devices Recalled in the U.S.: 2,712,767 U.S. Government:…
FDA D.I.S.C.O. Burst Edition: FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies
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 a recent FDA cancer therapeutic approval. On April 17, 2023, the FDA approved omidubicel-onlv, brand name…
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
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: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set…
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
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: Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Battery List Numbers: Plum 360: SUB0000864 Plum A+ and Plum A+3: SUB0000594 Devices…
Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto
Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement 15/05/23– San…
Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging
Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Mislabeling Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement 05/15/23– San Juan,…
BearCare Voluntarily Recalls Rechargeable Walnut Thermometer Due to the Potential for Skin Burns
Summary Company Announcement Date: May 10, 2023 FDA Publish Date: May 12, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for injuries, including skin burns & irritation Company Name: BearCare, Inc Brand Name: Brand Name(s) Product Description: Product Description Wearable Smart Thermometer Company Announcement Hauppauge, NY, May 10, 2023– BearCare, Inc….
Qué preguntar a su médico antes de tomar opiáceos
Image English Todo paciente debe hacer ciertas preguntas al recibir una nueva receta. Esto es especialmente importante cuando su médico, su dentista u otro profesional de la salud le prescriben un opiáceo, tal como hidrocodona, oxicodona, codeína o morfina. ¿Qué debe preguntar? 1.¿Por qué necesito este medicamento, es el adecuado para mí? Esta conversación podría…