Date Issued: January 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected…
Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination
Summary Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Precision Dose Inc. Brand Name: Brand Name(s) GUM Paroex Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups Company Announcement Precision…
Midwestern Pet Foods Voluntarily Recalls Pet Food Recall for Aflatoxin Health Risk
Summary Company Announcement Date: December 30, 2020 FDA Publish Date: December 30, 2020 Product Type: Animal & VeterinaryFood & Beverages Pet Food Reason for Announcement: Recall Reason Description Elevated levels of aflatoxin Company Name: Sportmix Brand Name: Brand Name(s) Product Description: Product Description Dog and Cat Food Company Announcement Midwestern Pet Foods, Inc., of Evansville,…
Amended – Flowers Foods Issues Voluntary Recall of Two Canyon Bakehouse Products Due to Possible Presence of Gluten
Summary Company Announcement Date: December 30, 2020 FDA Publish Date: December 30, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of gluten Company Name: Flowers Foods, Inc. Brand Name: Brand Name(s) Canyon Bakehouse Product Description: Product Description Canyon Bakehouse Everything Bagels Company Announcement Flowers Foods, Inc. (NYSE: FLO) has…
Divvies, LLC Issues Allergy Alert on Undeclared Milk and Eggs in Vanilla Cupcakes
Summary Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Food & Beverages Bakery Product/Mix Allergens Reason for Announcement: Recall Reason Description Undeclared milk and eggs Company Name: Divvies, LLC Brand Name: Brand Name(s) Product Description: Product Description Vanilla Cupcakes Company Announcement Divvies of Trumbull, CT is recalling Vanilla Cupcakes…
Lipari Foods Issues Allergy Alert on Undeclared Milk in Backroad Country Spicy Cajun Mix
Summary Company Announcement Date: December 30, 2020 FDA Publish Date: December 31, 2020 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Lipari Foods Brand Name: Brand Name(s) Backroad Country Product Description: Product Description Spicy Cajun Mix Company Announcement Lipari Foods of Warren, MI is…
Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination
Summary Company Announcement Date: December 28, 2020 FDA Publish Date: December 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: Brand Name(s) Product Description: Product Description Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Company Announcement Schaumburg, Illinois, Sunstar…
Legendary Baking Issues Allergy Alert for Potential Undeclared Pecan in Product Labeled as French Silk Pie
Summary Company Announcement Date: December 24, 2020 FDA Publish Date: December 28, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain undeclared pecans Company Name: Legendary Baking Brand Name: Brand Name(s) Legendary Baking Product Description: Product Description French Silk Pie Company Announcement Legendary Baking of Chaska, MN is voluntarily recalling…
UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
Date issued: December 29, 2020 The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. On December 29, 2020, the FDA issued the final guidance, Product Labeling for Laparoscopic Power…
B&I Overseas Trading Recalls Product Due to Potential Contamination with Listeria Monocytogenes
Summary Company Announcement Date: December 23, 2020 FDA Publish Date: December 24, 2020 Product Type: Food & Beverages Fish Foodborne Illness Reason for Announcement: Recall Reason Description Listeria Monocytogenes Company Name: B&I Overseas Trading, Inc Brand Name: Brand Name(s) Product Description: Product Description Herring in oil Company Announcement B&I Overseas Trading Inc from Van Nuys,…