Summary Company Announcement Date: March 22, 2023 FDA Publish Date: March 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) Impurity Company Name: Ascend Laboratories LLC. Brand Name: Brand Name(s) Ascend Laboratories Product Description: Product Description Dabigatran Etexilate Capsules, USP Company Announcement FOR IMMEDIATE RELEASE- Parsippany. New Jersey. Ascend…
Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication
Date Issued: March 23, 2023 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The…
Perfection Bakeries, d/b/a/ Aunt Millie’s Issues Allergy Alert on Undeclared Sesame in “Our Family Hot Dog Buns 8 Ct.”
Summary Company Announcement Date: March 21, 2023 FDA Publish Date: March 22, 2023 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen/Sesame Company Name: Perfection Bakeries D/B/A Aunt Millie’s Brand Name: Brand Name(s) Our Family Product Description: Product Description White Hot Dog Enriched Buns Company Announcement…
Second Nature Brands Issues Allergy Alert on Undeclared Wheat in Gluten Free Reese’s Pieces Brownie Brittle
Summary Company Announcement Date: March 23, 2023 FDA Publish Date: March 23, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Wheat Company Name: Second Nature Brands Brand Name: Brand Name(s) Sheila G’s Product Description: Product Description Gluten Free Reese’s Pieces Brownie Brittle Company Announcement Second Nature Brands of Madison Heights,…
FDA D.I.S.C.O. Burst Edition: FDA approval of Verzenio (abemaciclib) with endocrine therapy for patients with HR-positive, HER2-negative, node-positive, early breast cancer
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 3, 2023, the FDA approved abemaciclib (brand name…
Three Individuals Sentenced in Darknet Narcotics Trafficking Conspiracy Involving Distribution of Pills Pressed with Fentanyl
Department of JusticeU.S. Attorney’s OfficeDistrict of Columbia FOR IMMEDIATE RELEASEWednesday, March 22, 2023 The Conspiracy Involved Multiple Kilograms of Pills Purchased with Bitcoin WASHINGTON – The last of three defendants was sentenced Friday in the U.S. District Court for the District of Columbia for illegal sales of opioids on various Darknet markets. The Honorable John…
Mutual Trading Co., Inc Issues Allergy Alert for Undeclared Soy in Sauces
Summary Company Announcement Date: March 20, 2023 FDA Publish Date: March 20, 2023 Product Type: Food & Beverages Gravy/Sauces Allergens Reason for Announcement: Recall Reason Description Undeclared Soy Company Name: Mutual Trading, Inc. Brand Name: Brand Name(s) Product Description: Product Description Worcestershire Sauce, Chuno Sauce, and Take Out Tonkatsu Sauce Company Announcement Mutual Trading Co.,…
Updated – Scenic Fruit Company Recalls Frozen Organic Strawberries and Frozen Organic Tropical Blend Because of Possible Health Risk
Summary Company Announcement Date: March 16, 2023 FDA Publish Date: March 17, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Hepatitis A Company Name: Scenic Fruit Company Brand Name: Brand Name(s) Simply Nature, Vital Choice and others Product Description: Product Description Frozen Organic Strawberries and fruit blend Company Announcement ‘The company…
Perrigo Announces Voluntary Recall of Limited Quantity of Gerber® Good Start® SootheProTM Powdered Infant Formula
Summary Company Announcement Date: March 17, 2023 FDA Publish Date: March 17, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Cronobacter sakazakii contamination Company Name: Perrigo Company plc Brand Name: Brand Name(s) Gerber Good Start Product Description: Product Description Powdered Infant formula Company Announcement Dublin, Ireland – March 17, 2023…
Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown Coiled Cord Connection Failure
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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Product Models: Distribution Dates: March 6, 2012 to July 20, 2017 Devices…