Summary Company Announcement Date: November 19, 2024 FDA Publish Date: November 20, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description The product contains undeclared diclofenac and omeprazole Company Name: MXBBB Brand Name: Brand Name(s) Product Description: Product Description UMARY Hyaluronic Acid tablets Company Announcement MXBBB is voluntarily recalling 1 lot of UMARY ACID…
Children’s Health
Kids aren’t just small adults. From diet and nutrition to their reactions to medicine, their bodies are unique. Read these Consumer Updates to learn more. Content current as of: 12/21/2021 Health Topic(s) Article source: http://www.fda.gov/consumers/consumer-updates/childrens-health
Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Summary Company Announcement Date: November 18, 2024 FDA Publish Date: November 19, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo, Inc. Brand Name: Brand Name(s) Par Pharmaceutical Product Description: Product Description Clonazepam Orally Disintegrating Tablets, USP (C-IV) Company Announcement Endo, Inc. (OTCQX:…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
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 August 2, 2024, the FDA granted accelerated approval to…
Know When and How to Use Antibiotics, and When to Skip Them
[embedded content] Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused by bacteria – and none caused by viruses. Most often, antibiotics work by killing the targeted bacteria or by making it difficult for the bacteria to multiply. Talk to…
Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
The devices described in this recall are included in the related Letter to Health Care Providers. On November 15, 2024, the FDA added EVH devices (product code GEI) to the medical device shortage list. See the related Letter to Health Care Providers for the most current information on these devices. This recall involves removing certain…
Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers
November 15, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. On September 20, 2024, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for unresectable advanced or metastatic malignant pleural mesothelioma
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 September 17, 2024, the FDA approved pembrolizumab (brand name…
VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 06, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: VitalityVita Brand Name: Brand Name(s) VitalityVita Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, VitalityVita.com is…
Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 05, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: Boulla LLC Brand Name: Brand Name(s) Boulla LLC Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA,…