Summary Company Announcement Date: September 13, 2023 FDA Publish Date: September 08, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Microbial Contamination Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) TheraBreath Product Description: Product Description TheraBreath Kids Strawberry Splash Oral Rinse Company Announcement FOR IMMEDIATE RELEASE –…
Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly
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: One-Way Valve, 22F x 22M Product Codes: See Recall Database Entry Model Numbers: 74L2001714 74L2001715 74L2001716 74B2100237 Distribution Dates: January 26, 2022 to July 27,…
Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode
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 and Model Numbers: Distribution Dates: November 21, 2015, to June 29, 2023 Devices Recalled in the U.S.: 155,028 Date Initiated by Firm: July…
Bone Matrix Product: FDA Safety Communication – Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks
[Posted 09/12/2023] AUDIENCE: Patient, Health Professional, Infectious Disease, Surgery, Transplantation ISSUE: FDA is working closely with the Centers for Disease Control and Prevention (CDC) to investigate recent reports of a tuberculosis (TB) outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product. We are issuing this communication to increase…
Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Summary Company Announcement Date: September 11, 2023 FDA Publish Date: September 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Crystal formation which could potentially result in incorrect dosing Company Name: Novartis Pharmaceuticals Corporation Brand Name: Brand Name(s) Product Description: Product Description Sandimunne Oral Solution (cyclosporine oral solution, USP) 100 mg/mL Company Announcement…
Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to an Isolated Manufacturing Issue
Summary Company Announcement Date: September 08, 2023 FDA Publish Date: September 08, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Microbial Contamination Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) TheraBreath Product Description: Product Description TheraBreath Kids Strawberry Splash Oral Rinse Company Announcement FOR IMMEDIATE RELEASE –…
Hua Da Trading Inc dba Wefun Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: August 25, 2023 FDA Publish Date: September 05, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared drug, Sildenafil Company Name: Hua Da Trading Inc dba Wefun Inc Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – 08/25/2023…
Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops
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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to May 19, 2023 Devices…
UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers
August 31, 2023 The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure health care providers are aware of the latest recalls and recommendations to users. Since June 2023, Getinge/Maquet/Datascope initiated…
WEFUN Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: August 25, 2023 FDA Publish Date: September 05, 2023 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared drug, Sildenafil Company Name: WEFUN Inc. Brand Name: Brand Name(s) Product Description: Product Description Dietary Supplement with undeclared Sildenafil Company Announcement FOR IMMEDIATE RELEASE – 08/25/2023 – Brooklyn, New York, WEFUN…