Español September 29, 2023 The FDA is providing an update to consumers, health care providers, and facilities about certain surgical N95 respirators and masks manufactured by O&M Halyard. This update includes the current recommendations for these products based on new data and information provided by O&M Halyard. The FDA will continue to work with O&M…
SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance
Summary Company Announcement Date: September 27, 2023 FDA Publish Date: September 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential cross contamination with non-antibacterial beta-lactam drug substance Company Name: Scynexis, Inc. Brand Name: Brand Name(s) Brexafemme Product Description: Product Description Antifungal oral medication Company Announcement JERSEY CITY, N.J., Sept. 27, 2023 (GLOBE…
VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus
Summary Company Announcement Date: September 22, 2023 FDA Publish Date: September 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Bacillus cereus Company Name: Potential contamination with Bacillus cereus Brand Name: Brand Name(s) VistaPharm Product Description: Product Description Sucralfate Oral Suspension 1g/10mL Company Announcement FOR IMMEDIATE RELEASE – September 22,…
Universal Meditech Inc. Expands Nationwide Recall to All Products Manufactured between March 2021 and November 2022
Summary Company Announcement Date: September 13, 2023 FDA Publish Date: September 22, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product Safety/Defect Company Name: Universal Meditech Inc. Brand Name: Brand Name(s) Healthy Wiser and more Product Description: Product Description Company Announcement AMENDED on Sep 13, 20235288 Spring Mtn. Rd., Suite 103Las Vegas,…
Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile
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: Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Product Codes: See Recall Database Entry Lot number: 3B085 Distribution Dates: April 20, 2023…
Church & Dwight Issues Voluntary Nationwide Recall of One Specific Lot of TheraBreath Strawberry Splash for Kids 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to Microbial Contamination Identified as Yeast (Candida Parapsilosis)
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…