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 Scalable Bradycardia Platform (SBP) Pacemakers: Assurity™ and Endurity™ Distribution Dates: April 29, 2015 to February 20, 2019 Devices Recalled in the U.S.: 61,973 Date Initiated by Firm:…
Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
Summary Company Announcement Date: May 10, 2021 FDA Publish Date: May 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Company Name: Scentsational Soaps & Candles, Inc. Brand Name: Brand Name(s) Goose Creek, COCO TKO Product Description: Product Description Hand Sanitizer Company Announcement Scentsational Soaps…
Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Recall of DIBAR Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)
Summary Company Announcement Date: May 11, 2021 FDA Publish Date: May 12, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Dibar Nutricional S. de R.L. de C.V. Brand Name: Brand Name(s) DIBAR Labs, ProtectoRx Product Description: Product Description Hand Sanitizer Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S….
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma
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 have another quick update on a recent FDA cancer drug approval. On May 5, 2021, FDA granted accelerated approval to pembrolizumab…
Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues
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 HeartWare HVAD System Instructions for Use and Patient Manual that accompany components including HeartWare HVAD Pump, Controller, Driveline Cable, Driveline Cover, and Surgical Tool Kits Models: HVAD…
Temporada de huracanes: Prepárese
Image Cuando empiezan a soplar los vientos huracanados y las lluvias torrenciales elevan el nivel del agua, tiene que estar preparado. Los cortes de energía eléctrica significan que los alimentos y medicamentos refrigerados pueden estropearse. Las inundaciones pueden contaminar el agua del grifo y las provisiones de emergencia no almacenadas adecuadamente con las alcantarillas, productos…
Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil
Summary Company Announcement Date: May 11, 2021 FDA Publish Date: May 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil and Sildenafil Company Name: Yamtun7 Brand Name: Brand Name(s) Product Description: Product Description Male Sexual Enhancement Dietary Supplement Company Announcement Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon…
Hurricane Season: Be Prepared
Image Español When gale-force winds start blowing and torrential rains raise water levels, you need to be ready. Power outages mean refrigerated food and medicine supplies may spoil. Floods may contaminate tap water and emergency supplies not stored properly with sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants. If the storm or flood is…
Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% Lidocaine HCl Injection, USP Due to Mislabeling
Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to mislabeling Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL Company…
Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate
Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Company Announcement Hospira,…