Summary Company Announcement Date: June 27, 2022 FDA Publish Date: June 30, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Contain Tadalafil Company Name: Loud Muscle Science, LLC Brand Name: Brand Name(s) Launch Sequence Product Description: Product Description Launch Sequence Aphrodisia and Euphoria Capsules Company Announcement FOR IMMEDIATE RELEASE – 6/27/22 – Hauppauge,…

Date Issued: June 30, 2022 The U.S. Food and Drug Administration (FDA) is updating the May 2021 Safety Communication to alert the public that Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland is currently unaccredited and uncertified to perform mammography and cannot legally provide mammography services. The facility’s Mammography Quality…

July 1, 2022  The U.S. Food and Drug Administration is providing information to health care professionals to help their patients obtain access to medically necessary specialty, amino acid-based and metabolic infant formula products. The FDA is continuing to work to ensure infants and individuals with medical conditions who rely on certain specialty, amino acid-based and…

[Posted 06/30/2022] AUDIENCE: Patient, Health Professional, Pharmacy, Oncology  ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra was…

Summary Company Announcement Date: June 28, 2022 FDA Publish Date: June 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect labeling Company Name: Bryant Ranch Prepack Inc. Brand Name: Brand Name(s) Bryant Ranch Prepack Inc. Product Description: Product Description Morphine Sulfate 30 mg Extended-Release tablets Company Announcement 06/28/2022 – Burbank, California, Bryant…

Date Issued: June 28, 2022 The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral…

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: SafeStar 55 Breathing System Filter Product Model Numbers: MP01790 Lot Number: LT2103 Devices Recalled in the U.S.: 35,950 Dates distributed: August 18, 2021, to October…

On October 28, 2019, the FDA issued a Safety Communication to provide an update on Type III Endoleaks Associated with Use of Endologix AFX Endovascular AAA Graft Systems. October 15, 2018 – The FDA has issued a Class I recall to notify patients and health care providers about the risk of Type III endoleaks with…

Summary Company Announcement Date: June 22, 2022 FDA Publish Date: June 22, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Company Name: BD Brand Name: Brand Name(s) Product Description: Product…

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: Medtronic HVAD Batteries Product Codes: See Recall Database Entry Model Number: 1650DE Manufacturing Dates: April 13, 2021 to April 19, 2021 Distribution Dates: April 20,…