Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Delivery System Issues Potential inability to release the delivery system Company Name: Boston Scientific Corporation Brand Name: Brand Name(s) LOTUS Edge™ Aortic Valve System Product Description: Product Description LOTUS Edge™ Aortic Valve…
Weis Markets Issues Recall for Possible Foreign Matter Contamination in Weis Ice Cream Products
Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 10, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May be contaminated with extraneous material Company Name: Weis Markets Brand Name: Brand Name(s) Weis, Klein’s, Nelson’s Product Description: Product Description Ice cream products Company Announcement Weis Markets today said it…
What Is Gene Therapy? How Does It Work?
[embedded content] Español The genes in your body’s cells play an important role in your health — indeed, a defective gene or genes can make you sick. Recognizing this, scientists have been working for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure or prevent a disease or…
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 – Letter to Clinical Laboratory Staff and Health Care Providers
January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false negative results may occur with any molecular test for the detection of SARS-CoV-2 if a mutation…
Birmingham Man Pleads Guilty to Conspiracy for Making Unapproved Drug Products in His Kitchen and Warehouse
Department of JusticeU.S. Attorney’s OfficeNorthern District of Alabama FOR IMMEDIATE RELEASEThursday, January 7, 2021 BIRMINGHAM, Ala. – A Birmingham man today pleaded guilty to making unapproved drug products in his kitchen and warehouse, and marketing and selling them as a cancer treatment, announced U.S. Attorney Prim F. Escalona and U.S. Food and Drug Administration (FDA) Office of…
Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter
Summary Company Announcement Date: January 08, 2021 FDA Publish Date: January 08, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Fresenius Kabi USA Brand Name: Brand Name(s) Fresenius Kabi Product Description: Product Description Ketorolac Tromethamine Injection, USP, 30 mg/mL Company Announcement Fresenius Kabi USA is voluntarily recalling…
Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA exceeds acceptable daily intake limit Company Name: Nostrum Laboratories Brand Name: Brand Name(s) Nostrum Laboratories Product Description: Product Description Metformin HCl Extended Release Tablets, USP 750 mg Company Announcement Nostrum Laboratories, Inc….
2021 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2021 Safety Communications Content current as of: 01/04/2021 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2021-safety-communications
Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol
Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contaminated with Methanol Company Name: Essaar Inc. Brand Name: Brand Name(s) Soho Fresh Product Description: Product Description 70% Rubbing Alcohol Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70%…
Dole Fresh Vegetables Announces Limited Voluntary Recall of Dole™ Sesame Asian Chopped Salad Kit Due to Undeclared Allergens
Summary Company Announcement Date: January 05, 2021 FDA Publish Date: January 05, 2021 Product Type: Food & Beverages Prepared Food Allergens Reason for Announcement: Recall Reason Description Undeclared eggs Company Name: Dole Fresh Vegetables, Inc. Brand Name: Brand Name(s) Product Description: Product Description Sesame Asian Chopped Salad Kit Company Announcement Dole Fresh Vegetables, Inc. is…