Summary Company Announcement Date: September 20, 2021 FDA Publish Date: September 21, 2021 Product Type: Drugs Pharmaceutical Quality Reason for Announcement: Recall Reason Description Lack of sterility assurance. Company Name: IntegraDose Compounding Services, LLC Brand Name: Brand Name(s) IntegraDose Compounding Services, LLC Product Description: Product Description Company Announcement Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily…
Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device
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: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology Models Numbers: Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX,…
Microneedling Devices: Getting to the Point on Benefits, Risks and Safety
Image Español Being pricked by tiny needles may sound like a strange way to make your skin look better, but that’s the concept behind a skin care technique called microneedling. People are using microneedling in a variety of ways from reducing scarring, to treating fine lines and wrinkles. It is important to be aware of…
Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set
DATE NOTIFICATION INITIATED: August 18, 2021 PRODUCT / LOT NUMBER: Level 1® Fluid WarmerModel Numbers: H-1000, H-500 Level 1® Fluid Warming SystemModel Numbers: H-1028, H-1200 NORMOFLO® Fluid WarmerModel Number: H-1025 Level 1® Normothermic I.V. Fluid Administration SetModel Numbers: D-100, D-300, D-50, D-60HL, D-70, DI-100, DI-300, DI-50, DI-60HL, DI-70 MANUFACTURER: Smiths Medical ASD Inc.Minneapolis, MN REASON:…
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits – Letter to Clinical Laboratory Staff and Health Care Providers
September 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a potential for false positive results with the Alinity m SARS-CoV-2 AMP Kit, List Number 09N78-095, and Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096. The false positive results may be related to current mixing…
Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-nitroso-varenicline above acceptable daily intake level Company Name: Pfizer Brand Name: Brand Name(s) Product Description: Product Description Varenicline tablets Company Announcement Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1…
Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
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: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set Product Codes: See recall database Model Numbers: See full list of affected medical devices Manufacturing Dates:…
Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices – Letter to Health Care Providers
September 15, 2021 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the use of certain fluid warmers and the potential for aluminum leaching and exposing the patient to high levels of aluminum. Based on information reviewed by the FDA, aluminum leaching may occur when the fluid warmer is designed with…
FDA D.I.S.C.O. Burst Edition: FDA approval of Brukinsa (zanubrutinib) for adult patients with Waldenström’s macroglobulinemia
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 31, 2021, FDA approved zanubrutinib (brand name Brukinsa)…
5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC
Image Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated…