Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health. In addition, labeling distributed with…
Clinical Researchers Plead Guilty in Connection With Scheme to Falsify Drug Trial Data
U.S. Department of Justice FOR IMMEDIATE RELEASETuesday, June 8, 2021 A Florida nurse practitioner and a Florida woman pleaded guilty today to their participation in a conspiracy to falsify clinical trial data. According to court documents, Eduardo Navarro, 52, of Miami, and Nayade Varona, 50, of Port St. Lucie, worked at a clinical research site…
Former Supplement Company Owner Pleads Guilty to Unlawful Distribution of Steroid-Like Drugs
U.S. Department of Justice FOR IMMEDIATE RELEASEThursday, June 10, 2021 A New Jersey chiropractor pleaded guilty today to a felony charge relating to the distribution of steroid-like drugs in purported dietary supplements. According to court documents, Nicholas Andrew Puccio, 41, currently of Columbus, New Jersey, pleaded guilty to introducing an unapproved new drug into interstate…
Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results
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 Innova SARS-CoV-2 Antigen Rapid Qualitative Test (also distributed under the names Innova COVID-19 Self-Test Kit (3T Configuration), Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T Configuration), and Innova SARS-CoV-2-Antigen…
2021 Biologics Recalls
June 2, 2021 Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011 Product Numbers- VBM9901, VBM9905, VBM9910 and Lot Number- NMDS210011 Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product out of an abundance…
FDA D.I.S.C.O. Burst Edition: Approval of Opdivo (nivolumab) for resected esophageal or gastroesophageal junction cancer with residual disease who have received chemoradiotherapy and Rybrevant (amivantamab-vmjw) for locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
Podcast Welcome 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 2 recent FDA cancer drug approvals. On May 20, 2021, FDA approved nivolumab (brand name Opdivo) for…
Hospital Pharmacist Sentenced for Attempt to Spoil Hundreds of COVID Vaccine Doses
Department of JusticeU.S. Attorney’s OfficeEastern District of WisconsinTuesday, June 8, 2021 Acting United States Attorney Richard G. Frohling of the Eastern District of Wisconsin announced that on June 8, 2021, Steven R. Brandenburg (age: 46) of Grafton, Wisconsin, was sentenced to 36 months’ imprisonment for tampering with COVID vaccine doses at the hospital at which he…
Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) – Lot Number: NMDS210011
DATE NOTIFICATION INITIATED: June 2, 2021 PRODUCT / LOT NUMBER: FiberCel Fiber Viable Bone Matrix (“FiberCel”)Product Numbers: VBM9901, VBM9905, VBM9910Lot Number: NMDS210011 MANUFACTURER: Aziyo Biologics, Inc.Richmond, CA REASON: Aziyo Biologics, Inc., (“Aziyo”) is the manufacturer of record for FiberCel Fiber Viable Bone Matrix (“FiberCel”) and is voluntarily recalling one Lot of the FiberCel product, Donor…
Smilin’ Bob’s Voluntarily Recalls Smilin’ Bob’s Smoked Fish Dip Products Because of Possible Health Risk
Summary Company Announcement Date: June 07, 2021 FDA Publish Date: June 08, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Smilin’ Bob’s Brand Name: Brand Name(s) Smilin’ Bob’s Product Description: Product Description Smoked Fish Dip Company Announcement Smilin’ Bob’s is voluntarily recalling Smilin’ Bob’s Original Smoked Fish…
Beech-Nut Nutrition Company Issues a Voluntary Recall of One Lot of Beech-Nut Single Grain Rice Cereal and Also Decides to Exit the Rice Cereal Segment
Summary Company Announcement Date: June 08, 2021 FDA Publish Date: June 08, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Presence of Inorganic Arsenic above Guidance Levels Company Name: Beech-Nut Brand Name: Brand Name(s) Product Description: Product Description Stage 1, Single Grain Rice Cereal Company Announcement Beech-Nut Nutrition today has issued…