Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 17, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential of Listeria monocytogenes Company Name: Baker Farms Brand Name: Brand Name(s) Baker Farms, Kroger & SEG Grocers Product Description: Product Description Bagged Kale Company Announcement Baker Farms is recalling their…
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…
The Kroger Co. Issues Voluntarily Recall on 16-Ounce Kroger Bagged Kale Due to Possible Listeria Monocytogenes Contamination
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: The Kroger Co Brand Name: Brand Name(s) Product Description: Product Description Bagged Kale Product Company Announcement The Kroger Co. (NYSE: KR) is voluntarily recalling its 16-ounce Kroger…
Drew’s Organics, LLC Issues Voluntary Recall of Aldi Simply Nature Organic Poppy Seed Dressing for Potential Clostridium botulinum Contamination
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 16, 2021 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential for microbial growth Company Name: Drew’s Organics, LLC Brand Name: Brand Name(s) Simply Nature Product Description: Product Description Organic Poppy Seed Dressing Company Announcement Drew’s Organics, LLC of…
Baker Farms Recalls Various Brand Name of Kale Due to Listeria Monocytogenes Contamination
Summary Company Announcement Date: September 16, 2021 FDA Publish Date: September 17, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential of Listeria monocytogenes Company Name: Baker Farms Brand Name: Brand Name(s) Baker Farms, Kroger & SEG Grocers Product Description: Product Description Bagged Kale Company Announcement Baker Farms is recalling their…
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)…
Buurma Farms Inc. Recalls Plain (Flat) Parsley Due to Possible Health Risks
Summary Company Announcement Date: September 14, 2021 FDA Publish Date: September 15, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain Shiga-toxin producing E.coli Company Name: Buurma Farms Inc. Brand Name: Brand Name(s) Product Description: Product Description Plain (Flat Leaf) Parsley Company Announcement Buurma Farms Inc. of Willard, OH, is…