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: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System Product Models: all Reader…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
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 drug approval. On March 16, 2023, the FDA approved dabrafenib (brand name…
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS Product Description: Product Description Alcohol Antiseptic 80% Topical Solution…
Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.
Summary Company Announcement Date: April 03, 2023 FDA Publish Date: April 03, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for battery swelling and overheating. Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Readers in the FreeStyle Libre product family. Company Announcement This communication applies to the Readers…
Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply Product Description: Product Description Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential Bacillus Cereus Contamination in the Product
Summary Company Announcement Date: March 13, 2023 FDA Publish Date: March 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Bacillus cereus Contamination Company Name: Camber Pharmaceuticals, Inc. Brand Name: Brand Name(s) Product Description: Product Description Device & Drug Safety/Microbial Contamination/Bacillus cereus Company Announcement FOR IMMEDIATE RELEASE – 3/13/2023 – Piscataway, NJ,…
Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to January 13, 2023 Devices…
Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication
Date Issued: March 30, 2023 The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The devices of concern include: Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance…
Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: March 22, 2023 FDA Publish Date: March 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Ascend Laboratories LLC. Brand Name: Brand Name(s) Ascend Laboratories Product Description: Product Description Dabigatran Etexilate Capsules, USP Company Announcement FOR IMMEDIATE RELEASE- Parsippany. New Jersey. Ascend…
Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication
Date Issued: March 23, 2023 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The…