AUDIENCE: Consumers, Patients, Health Professionals ISSUE: The U.S. Food and Drug Administration (FDA) is providing important safety information to healthcare providers on the use of products containing live bacteria or yeast (commonly called probiotics) in preterm infants in hospital settings. BACKGROUND: FDA has issued a Dear Healthcare Provider (DHCP) Letter to provide important safety information to healthcare providers…
Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp. Company Name: Biomic Sciences Brand Name: Brand Name(s) Ion and Restore brands Product Description: Product Description Nasal Sprays Company Announcement ‘The…
Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp. Company Name: Biomic Sciences Brand Name: Brand Name(s) Ion and Restore brands Product Description: Product Description Nasal Sprays Company Announcement FOR…
Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter
Summary Company Announcement Date: October 02, 2023 FDA Publish Date: October 02, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Glass Particulates Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product Description 4.2% Sodium Bicarbonate Injection, USP, 1% Lidocaine HCl Injection, USP, and 2% Lidocaine HCl Injection, USP…
KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Summary Company Announcement Date: September 29, 2023 FDA Publish Date: October 03, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Oxycodone HCl tablet Company Name: KVK-Tech, Inc. Brand Name: Brand Name(s) Product Description: Product Description Betaxolol Tablets, USP Company Announcement FOR IMMEDIATE RELEASE – 09/29/2023 – Newtown, Pennsylvania, KVK-Tech, Inc….
Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
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…