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 The recall described in this notice is the same one that was announced in the FDA Safety Communication from June 27, 2019 Recalled Product MiniMed Model 500 Remote Control and…
Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached
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 Philips Medical System (Cleveland) Forte Gamma Camera System Forte (882020) Forte Jetstream (882290) Forte Jetstream upgrade (882291) Forte Jetstream AZ (882320) Forte Jetstream AZ upgrade (882321) Diamond…
Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products
Summary Company Announcement Date: October 31, 2019 FDA Publish Date: November 01, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potentially contain microbial contamination in the non-sterile Suturagel Company Name: Fagron Inc. Brand Name: Brand Name(s) Product Description: Product Description LETS GEL KIT Convenience Packs Company Announcement Fagron Inc. is voluntarily recalling all…
ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter
Summary Company Announcement Date: October 30, 2019 FDA Publish Date: October 30, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the presence of particulate matter Company Name: ICU Medical, Inc. Brand Name: Brand Name(s) ICU Medical, Inc. Product Description: Product Description Lactated Ringer’s Injection, USP and 0.9% Sodium Chloride Injection, USP…
Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples
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…
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…