Summary Company Announcement Date: December 17, 2021 FDA Publish Date: December 20, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Flowers Foods, Inc. Brand Name: Brand Name(s) Nature’s Own Product Description: Product Description Honey Wheat Bread (Single and 2 Pack) Company Announcement THOMASVILLE, Ga. – Flowers Foods,…
Bosket Bread Company Issues Allergy Alert on Undeclared Soy, Wheat, Milk, Sesame, Egg in Bread
Summary Company Announcement Date: December 18, 2021 FDA Publish Date: December 18, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared soy, wheat, milk, sesame, or egg. Company Name: Bosket Bread Company Brand Name: Brand Name(s) Bosket Bread Product Description: Product Description Bread products Company Announcement Bosket Bread Company LLC of…
P&G Issues Voluntary Recall of Aerosol Dry Conditioner Spray Products and Aerosol Dry Shampoo Spray Products
Summary Company Announcement Date: December 17, 2021 FDA Publish Date: December 17, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Due to the presence of benzene detected Company Name: The Procter & Gamble Company Brand Name: Brand Name(s) Pantene, Aussie, Herbal Essences, Waterl<ss, Old Spice, Hair Food Product Description: Product Description…
Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit Following a COVID-19 Vaccine – Letter to Clinical Laboratory Staff and Health Care Providers
December 17, 2021 The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false reactivity, or “false-positive”, Rapid Plasma Reagin (RPR; non-treponemal) test results, when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit, can occur in some people who received a COVID-19 vaccine. Based on…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Rituxan (rituximab) plus chemotherapy for pediatric cancer indications, and Keytruda (pembrolizumab) for adjuvant treatment of Stage IIB or IIC melanoma
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 two recent FDA cancer drug approvals. On December 2, 2021, the FDA approved rituximab (brand name…
Former West Hollywood Doctor and Company Associated with 1-800-GET-THIN Guilty of Massive Fraud Against Health Insurers
Department of JusticeU.S. Attorney’s OfficeCentral District of California FOR IMMEDIATE RELEASEThursday, December 16, 2021 LOS ANGELES – A former doctor and his company were found guilty today by a federal jury of scheming to defraud private insurance companies and the Tricare health care program for military service members by fraudulently submitting an estimated $355 million…
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks
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: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Model Numbers: See Recall Database Entry Manufacturing Dates: December 2011 to Present Distribution Dates: March…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma
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 two recent FDA cancer drug approvals. On November 29, 2021, the FDA approved pafolacianine (brand name…
Federal Jury Convicts Florida Man for Role in Defrauding FDA and Distributing Designer Anabolic Steroids Labeled as Dietary Supplements
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, December 10, 2021 On Dec. 9, a federal jury in Fort Lauderdale, Florida, convicted James Boccuzzi, 37, of Boca Raton, Florida, of one count of conspiracy to defraud the U.S. Food and Drug Administration (FDA) and one count of conspiracy to distribute controlled substances. Boccuzzi is the 11th defendant…
Voluntary Recall of Howling Cow Butter Almond Ice Cream Due to Undeclared Soy and Wheat
Summary Company Announcement Date: December 11, 2021 FDA Publish Date: December 13, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy, Wheat Company Name: Maryland & Virginia Milk Producers Cooperative Association Brand Name: Brand Name(s) Howling Cow Product Description: Product Description Howling Cow Butter Almond Ice Cream Pints Company Announcement…