[Posted 03/12/2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). The FDA is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following…
Surgical Mask and Gown Conservation Strategies – Letter to Healthcare Providers
The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak. The following conservation strategies for use by healthcare organizations and personnel are categorized…
BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris™ System PC Units and Modules
Summary Company Announcement Date: March 09, 2020 FDA Publish Date: March 10, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Infusion pump may not operate as expected Company Name: Becton, Dickinson, and Company Brand Name: Brand Name(s) Product Description: Product Description BD Alaris System PC Units and Modules Company Announcement BD (Becton,…
Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing
Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals U.S.A., Inc. Product Description: Product Description Phenytoin Oral Suspension USP, 125 mg/5 mL Company Announcement Taro Pharmaceuticals…
Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors
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 Alaris System Pump Modules Lot Numbers: All Lots of affected Models Model Number: BD Alaris™ System PC Unit Model 8000, software versions 9.5 and prior BD Alaris™…
Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates
Summary Company Announcement Date: March 04, 2020 FDA Publish Date: March 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential Presence of Small Particulates Company Name: Hikma Pharmaceuticals USA Inc. Brand Name: Brand Name(s) Product Description: Product Description Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial Company Announcement Hikma Pharmaceuticals PLC (Hikma,…
Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning – Due to Restricting Use for Allergic Rhinitis
[Posted 03/04/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks…
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is informing patients, health care providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. Software to exploit these vulnerabilities in certain situations is already publicly…
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
Date issued: February 25, 2020 The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment…
American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: February 27, 2020 FDA Publish Date: February 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: American Health Packaging Brand Name: Brand Name(s) American Health Packaging Product Description: Product Description Ranitidine Tablets, USP 150mg Company Announcement American Health Packaging has voluntarily recalled eleven (11)…