Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton due to Vial Breakage UPDATED November 28, 2022

Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE – November 28,…

Rocky Mountain Pies, LLC Issues Allergy Alert on Undeclared (Tree Nuts Almonds) in Red Button Vintage Creamery 31.88 oz French Silk Pie

Summary Company Announcement Date: November 29, 2022 FDA Publish Date: November 29, 2022 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared almond Company Name: Rocky Mountain Pies, LLC Brand Name: Brand Name(s) Red Button Vintage Creamery Product Description: Product Description French Silk Pie Company Announcement Rocky Mountain Pies,…

FDA D.I.S.C.O. Burst Edition: FDA approval of Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements

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 September 30, 2022, the FDA granted accelerated approval to…

Weis Markets Issues an Allergy Alert for Weis Quality Premium Sea Salt and Caramel Ripple Ice Cream Due to Undeclared Soy and Coconut Allergens

Summary Company Announcement Date: November 23, 2022 FDA Publish Date: November 23, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy and Coconut Allergens Company Name: Weis Markets Brand Name: Brand Name(s) Weis Quality Product Description: Product Description Premium Sea Salt and Caramel Ripple Ice Cream Company Announcement Sunbury, PA…

FDA D.I.S.C.O. Burst Edition: FDA approvals of Imjudo (tremelimumab) in combination with durvalumab for unresectable hepatocellular carcinoma, and Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma

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 two recent FDA cancer drug approvals. On October 21, 2022, the FDA approved tremelimumab (brand name…

Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment

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: WatchCare Incontinence Management System (IMS)  Product Models:  P7900B Centrella Bed with WatchCare P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J P00697902: Hospital…

Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

[Posted 11/22/2022]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). FDA’s review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia,…

Doctor Sentenced for Accepting Illegal Kickback Payments in Return for Writing Prescriptions for Compounded Drugs, Will Pay $3.1 Million in Civil Settlement

Department of JusticeEastern District of Virginia FOR IMMEDIATE RELEASEFriday, November 18, 2022 ALEXANDRIA, Va. – A doctor licensed in Virginia, Maryland, and elsewhere was sentenced today to 3 years for writing and referring compounded drug prescriptions in return for illegal kickback payments. The doctor previously entered into a civil settlement with the Government that requires him…