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…
Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure
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 July 20, 2017 Devices…
Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When Connected with an Oxygen Concentrator
Summary Company Announcement Date: March 10, 2023 FDA Publish Date: March 10, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator Company Name: Baxter International Inc. Brand…
UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants – FDA Safety Communication
Date Issued: March 8, 2023 The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on September 8, 2022, the FDA released a safety communication informing the public of reports of cancers, including SCC and various…
Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers
March 7, 2023 The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs)…
Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility
Summary Company Announcement Date: March 03, 2023 FDA Publish Date: March 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-sterility Company Name: Pharmedica USA LLC Brand Name: Brand Name(s) Purely Soothing Product Description: Product Description 15% MSM Drops Company Announcement Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of…
All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication – FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information
[Posted 03/03/2023] AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event reporting of false negative skin test results with certain lots of ALK-Abello’s Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only. Some of these reports of…
Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles
Summary Company Announcement Date: March 01, 2023 FDA Publish Date: March 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility. Company Name: Apotex Corp. Brand Name: Brand Name(s) Product Description: Product Description Brimonidine Tartrate Ophthalmic Solution, 0.15% Company Announcement FOR IMMEDIATE RELEASE – March 01, 2023 – Weston, Florida,…
Getinge/Maquet Cardiohelp System: Potential Insufficient Packaging Sterility with HLS Set Advanced – Letter to Health Care Providers
March 1, 2023 The U.S. Food and Drug Administration (FDA) is alerting health care facilities and providers about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump. On February 13, 2023, Getinge/Maquet issued…