Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: March 10, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Reports of hearing performance degradation Company Name: Advanced Bionics Brand Name: Brand Name(s) HiRes Ultra and Ultra 3D Product Description: Product Description Cochlear implants Company Announcement Advanced Bionics (AB), a global leader…

Fecal Microbiota for Transplantation: Safety Alert – Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

[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…

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…

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…

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…