[Posted 09/13/2019] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory…
Urban Remedy Voluntarily Recalls 76 Salads, Wraps That May Contain E.Coli Bacteria No Illnesses Reported, Company Taking Preventive Action
Summary Company Announcement Date: September 12, 2019 FDA Publish Date: September 13, 2019 Product Type: Food & BeveragesPrepared Food Reason for Announcement: Recall Reason Description may be contaminated with E. coli Company Name: Urban Remedy Brand Name: Brand Name(s) Urban Remedy Product Description: Product Description Salads and Wraps Company Announcement Urban Remedy, a California-based producer…
Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication – Due to Rare but Severe Lung Inflammation
[Posted 09/13/2019] AUDIENCE: Patient, Health Professional, Oncology ISSUE: FDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire…
Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Matcha Candies
Summary Company Announcement Date: September 10, 2019 FDA Publish Date: September 12, 2019 Product Type: Food & BeveragesCandy/Gum (without chocolate) Reason for Announcement: Recall Reason Description Undeclared eggs and milk Company Name: RONG SHING Brand Name: Brand Name(s) Product Description: Product Description FuPaiYuan Matcha candy Company Announcement Rong Shing of Brooklyn, NY is recalling its 450g…
Stark Group International Issues Allergy Alert on Undeclared Milk Allergens in Ritter Sport KAFFEESPLITTER – 3.5 Ounce /100 Gram
Summary Company Announcement Date: September 10, 2019 FDA Publish Date: September 12, 2019 Product Type: Food & BeveragesMeal Replacements Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Stark Group International Brand Name: Brand Name(s) Ritter Sport Product Description: Product Description Ritter Sport -KAFFEESPLITTER Company Announcement Stark Group International of Greenvale, NY is recalling…
Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Nougat Candies
Summary Company Announcement Date: September 10, 2019 FDA Publish Date: September 12, 2019 Product Type: Food & BeveragesCandy/Gum (without chocolate) Reason for Announcement: Recall Reason Description Undeclared eggs and milk Company Name: RONG SHING Brand Name: Brand Name(s) Product Description: Product Description FuPaiYuan Nougat candy Company Announcement Rong Shing of Brooklyn, NY is recalling its…
Hy-Vee Voluntarily Recalls Several Hy-Vee Mealtime Asian Entrees Due to Undeclared Milk Allergen
Summary Company Announcement Date: September 10, 2019 FDA Publish Date: September 11, 2019 Product Type: Food & BeveragesPrepared Food Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Hy-Vee Brand Name: Brand Name(s) Product Description: Product Description Mealtime Asian Entrees Company Announcement Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling seven…
Recall of Yellowfin Tuna Steaks Issued
Summary Company Announcement Date: September 10, 2019 FDA Publish Date: September 11, 2019 Product Type: Food & BeveragesFish Reason for Announcement: Recall Reason Description Potentially elevated levels of histamine or scombroid fish poisoning Company Name: Alfa International Seafood, Inc. Brand Name: Brand Name(s) Alfa International Seafood, Inc Product Description: Product Description Refrigerated, wild-caught yellowfin tuna…
Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup
Summary Company Announcement Date: January 19, 2018 FDA Publish Date: January 19, 2018 Product Type: Food & BeveragesAllergensFood & Beverage Safety Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Ottogi America, Inc. Brand Name: Brand Name(s) Product Description: Product Description Rice Cake Soup Company Announcement Ottogi America, Inc. of Gardena, CA is recalling…
Allergy Alert Issued in Select North Atlantic Whole Foods Market Stores for Undeclared Almond Flour in Cheesecake Bars
Summary Company Announcement Date: January 18, 2018 FDA Publish Date: January 18, 2018 Product Type: Food & BeveragesAllergensFood & Beverage Safety Reason for Announcement: Recall Reason Description Undeclared Almond Flour Company Name: Whole Foods Market Brand Name: Brand Name(s) Whole Foods Market Product Description: Product Description Cheesecake bars Company Announcement Nine Whole Foods Market stores…