Summary Company Announcement Date: July 18, 2022 FDA Publish Date: July 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared active pharmaceutical ingredient tadalafil Company Name: MKS Enterprise LLC Brand Name: Brand Name(s) Dose Vital Product Description: Product Description Company Announcement This product was found to contain the undeclared active pharmaceutical ingredient…
FDA D.I.S.C.O.: Burst Edition: FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On March 23, 2022, the FDA approved Pluvicto (active ingredient…
For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
Date Issued: July 15, 2022 The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox…
Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Summary Company Announcement Date: July 15, 2022 FDA Publish Date: July 15, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination with Gluconacetobacter liquefaciens Company Name: Vi-Jon, LLC Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor Company Announcement July 14, 2022…
American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
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: COVID Test Kit Nonsterile and Clean Catch Urine Kit Product Codes: JSM Lot Numbers: See recall database entry Distribution Dates: February 1, 2021, to…
Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate
Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible particulate Company Name: Hospira Inc, A Pfizer Company Brand Name: Brand Name(s) Product Description: Product Description Propofol Injection Emulsion, USP Company Announcement Hospira, Inc., a Pfizer company, is voluntarily…
FDA Guards Against Food Spoilage, Contamination
Español At a Food and Drug Administration laboratory in Jefferson, Arkansas, sensory analysts’ noses—not their microscopes—are their essential tools. These specialists in this FDA regional lab use their sense of smell for detecting odors of decomposition to make sure domestic and imported seafood and seafood products are fit for consumption. These analysts are part of…
Caution Consumers:
Image Don’t Fall for False Claims When you’re browsing, one of the best ways to protect yourself from fake, and even possibly harmful, products is asking whether a claim sounds too good to be true, or if it contradicts what you’ve heard from reputable sources. On July 12, 2022, the U.S. Food and Drug Administration…
Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches
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 Name: Flow-c and Flow-e Anesthesia Systems Product Codes: 6887700, 6887900 Product Serial Numbers: See Recall Database Entries Devices Recalled in the U.S.: 64 Dates distributed: June…
Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens
Summary Company Announcement Date: July 05, 2022 FDA Publish Date: July 06, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for the label to be missing on some pens. Company Name: Mylan Pharmaceuticals Inc. Brand Name: Brand Name(s) Mylan Pharmaceuticals Inc. Product Description: Product Description Insulin Glargine (Insulin glargine-yfgn) Injection Pens Company…