Summary Company Announcement Date: May 14, 2021 FDA Publish Date: May 17, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Compromised hermetic seal/Microbial growth Company Name: Faribault Foods, Inc Brand Name: Brand Name(s) S&W and O Organic Product Description: Product Description Organic Black Beans and Organic Chili Beans Company Announcement Faribault…
Recall Expansion of Durisan Non-Alcohol Hand Sanitizer
Summary Company Announcement Date: May 14, 2021 FDA Publish Date: May 17, 2021 Product Type: Drugs Contaminants Reason for Announcement: Recall Reason Description Product is contaminated with Burkholderia contaminans Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer Company Announcement Sanit Technologies LLC d/b/a Durisan is updating…
Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions
Summary Company Announcement Date: May 07, 2021 FDA Publish Date: May 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to improper storage temperature conditions Company Name: Novo Nordisk Brand Name: Brand Name(s) Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Description: Product Description Product Samples Company Announcement Novo Nordisk is voluntarily recalling…
Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol
Summary Company Announcement Date: May 12, 2021 FDA Publish Date: May 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Global Sanitizers Brand Name: Brand Name(s) Medically Minded Product Description: Product Description Hand Sanitizer Company Announcement Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of…
Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life
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 Scalable Bradycardia Platform (SBP) Pacemakers: Assurity™ and Endurity™ Distribution Dates: April 29, 2015 to February 20, 2019 Devices Recalled in the U.S.: 61,973 Date Initiated by Firm:…
BUBS Naturals of Encinitas, CA Is Voluntarily Recalling Certain Lots of Its MCT Oil Powder Product Due to Undeclared Milk
Summary Company Announcement Date: May 14, 2021 FDA Publish Date: May 14, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: BUBS Naturals Brand Name: Brand Name(s) BUBS Naturals Product Description: Product Description MCT Oil Powder Company Announcement BUBS Naturals of Encinitas, CA is voluntarily recalling certain lots…
Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
Summary Company Announcement Date: May 10, 2021 FDA Publish Date: May 13, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Company Name: Scentsational Soaps & Candles, Inc. Brand Name: Brand Name(s) Goose Creek, COCO TKO Product Description: Product Description Hand Sanitizer Company Announcement Scentsational Soaps…
JOLLY TIME® Pop Corn Issues Allergy Alert on Undeclared Milk in Healthy Pop® Kettle Corn 100’s (4 count)
Summary Company Announcement Date: May 12, 2021 FDA Publish Date: May 13, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: JOLLY TIME Pop Corn Brand Name: Brand Name(s) Jolly Time Product Description: Product Description Kettle Corn Company Announcement JOLLY TIME Pop Corn today issued a voluntary recall…
Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Recall of DIBAR Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)
Summary Company Announcement Date: May 11, 2021 FDA Publish Date: May 12, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of methanol Company Name: Dibar Nutricional S. de R.L. de C.V. Brand Name: Brand Name(s) DIBAR Labs, ProtectoRx Product Description: Product Description Hand Sanitizer Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S….
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma
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 another quick update on a recent FDA cancer drug approval. On May 5, 2021, FDA granted accelerated approval to pembrolizumab…