Department of JusticeU.S. Attorney’s OfficeDistrict of Colorado FOR IMMEDIATE RELEASESaturday, August 28, 2021 DENVER – In two separate cases, the U.S. Attorney’s Office for the District of Colorado held nurses accountable after they stole controlled substances from their patients. Katie Muhs, age 34, of Littleton, CO, was sentenced for her felony conviction for illegally obtaining…
Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Summary Company Announcement Date: August 27, 2021 FDA Publish Date: August 30, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Teligent Pharma, Inc. Brand Name: Brand Name(s) Product Description: Product Description Lidocaine HCl Topical Solution 4% Company Announcement Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl…
FDA 101: Dietary Supplements
The law defines dietary supplements in part as products taken by mouth that contain a “dietary ingredient.” Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet. Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids….
Rocky Top Farms Issues Allergy Alert on Undeclared Milk in “Cherry Butter”
Summary Company Announcement Date: August 26, 2021 FDA Publish Date: August 30, 2021 Product Type: Food & Beverages Fruit/Fruit Product Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Rocky Top Farms Brand Name: Brand Name(s) Rocky Top Farms Product Description: Product Description Cherry Butter Company Announcement Rocky Top Farms of Ellsworth, MI,…
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
Date Issued: August 26, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Madison Avenue Radiology Center 190th Broadway, located in New York, New York, on or after February 26, 2019, about possible problems with the quality of their mammograms. Recommendations for Patients If you have had a more…
FDA D.I.S.C.O. Burst Edition: FDA approval of Welireg (belzutifan) for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery
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 have a quick update on another recent FDA cancer drug approval. On August 13, 2021, FDA approved belzutifan (brand name Welireg),…
Former Nurse Charged with Tampering with Consumer Products
Department of JusticeU.S. Attorney’s OfficeEastern District of Michigan FOR IMMEDIATE RELEASEWednesday, August 25, 2021 An indictment was unsealed today charging former registered nurse Mary Cheatham, 41, of Ypsilanti, MI, with one count of tampering with a consumer product, specifically the Schedule II controlled substance hydromorphone, which is used for pain relief, announced Acting United States…
Four Charged in Alleged $150 Million Payment Processing Scheme
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, August 26, 2021 Four individuals have been charged in the District of Massachusetts with conspiring to deceive banks and credit card companies into processing more than $150 million in credit and debit card payments on behalf of merchants involved in prohibited and high-risk businesses, including online gambling, debt collection,…
Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng – Letter to Health Care Providers
August 25, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health…
FDA D.I.S.C.O. Burst Edition: FDA approval of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for first-line treatment of adult patients with advanced renal cell carcinoma
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 August 10, 2021, FDA approved the combination of lenvatinib…