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 ECHELON FLEX™ ENDOPATH® Staplers: ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A) ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A) ECHELON Flex…
Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: October 25, 2019 FDA Publish Date: October 25, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to above levels of N-Nitrosodimethylamine (NDMA) Company Name: Lannett Company, Inc. Brand Name: Brand Name(s) Lannett Company, Inc. Product Description: Product Description Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Company Announcement Lannett…
Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling
Image Although breast cancer is a disease usually associated with women, men can get it too. Because male breast cancer is rare, there is very limited information on how to treat men diagnosed with the disease. “In the absence of better information to guide us, we tend to treat men with breast cancer the same…
Golden Dragon Fortune Cookies Inc. Issues Allergy Alert on Undeclared Milk in Chinese Almond Cookies
Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 28, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain undeclared milk Company Name: Golden Dragon Fortune Cookies Inc. Brand Name: Brand Name(s) Golden Dragon Inc. Product Description: Product Description Chinese Almond Cookies Company Announcement Golden Dragon Fortune Cookies…
North Bay Produce Voluntarily Recalls Fresh Apples Because of Possible Health Risk
Summary Company Announcement Date: October 25, 2019 FDA Publish Date: October 28, 2019 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Listeria monocytogenes Company Name: North Bay Produce, Inc. Brand Name: Brand Name(s) Great Lakes, more Product Description: Product Description Fresh apples varieties: Company Announcement North Bay…
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication
Date Issued: October 28, 2019 The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) when Endologix AFX endovascular grafts (AFX with Strata, AFX with Duraply, or AFX2) are used for the treatment of abdominal aortic aneurysms (AAA). We’ve previously communicated about the greater risk…
GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil
Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 22, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Tadalafil Company Name: GL Holdings Brand Name: Brand Name(s) Green Lumber Product Description: Product Description Dietary supplements for male sexual enhancement Company Announcement FOR IMMEDIATE RELEASE – Newport Beach, California. GL Holdings…
Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance
Summary Company Announcement Date: October 25, 2019 FDA Publish Date: October 26, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of foreign substance Company Name: Mylan Pharmaceuticals Inc. Brand Name: Brand Name(s) Mylan Pharmaceuticals Inc. Product Description: Product Description Alprazolam Tablets, USP C-IV 0.5 mg Company Announcement Mylan Pharmaceuticals Inc. is…
Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Summary Company Announcement Date: October 25, 2019 FDA Publish Date: October 25, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description May contain N-Nitrosodimethylamine (NDMA) Company Name: Novitium Pharma Brand Name: Brand Name(s) Novitium Pharma Product Description: Product Description Ranitidine Hydrochloride Capsules 150 mg and 300 mg Company Announcement Novitium Pharma LLC (Novitium) is…
Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.
Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description May Contain N-Nitrosodimethylamine (NDMA) Company Name: Sanofi Brand Name: Brand Name(s) Product Description: Product Description Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products) Company Announcement As a precautionary measure, Sanofi on…