Summary Company Announcement Date: November 13, 2019 FDA Publish Date: November 13, 2019 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Due to unapproved active ingredient (sildenafil) Company Name: Nature’s Rx Brand Name: Brand Name(s) Silver Bullet Product Description: Product Description Male Enhancement Capsules Company Announcement Nature’s Rx is voluntarily recalling lot: 01251ZX1,…
The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
Date Issued: November 28, 2017 Audiences: People taking or considering taking biotin, vitamin B7, supplements Physicians and other health care providers who order lab tests Lab personnel Lab test developers Specialties: All physicians and health care providers Product: Many lab tests use biotin technology due to its ability to bond with specific proteins which can…
Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Description Lot# Expiration Date Ranitidine Tablets, USP 150mg AR180483B 3/31/2020 Ranitidine Tablets, USP 150mg AR180559A 3/31/2020 Ranitidine Tablets, USP 150mg AR180560A 3/31/2020 Ranitidine Tablets, USP 150mg AR180594A 3/31/2020 Ranitidine Tablets, USP 150mg AR180595A 3/31/2020 Ranitidine Tablets, USP 150mg AR180675A 4/30/2020 Ranitidine Tablets, USP 150mg AR180829A 4/30/2020 Ranitidine Tablets, USP 150mg AR180831A 5/31/2020 Ranitidine Tablets, USP…
UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
Date Issued: November 5, 2019 The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA…
Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
Summary Company Announcement Date: November 08, 2019 FDA Publish Date: November 08, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Product is tainted with sildenafil Company Name: Med Man Distribution Brand Name: Brand Name(s) Product Description: Product Description Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement Company…
American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: November 08, 2019 FDA Publish Date: November 08, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: American Health Packaging Brand Name: Brand Name(s) Product Description: Product Description Ranitidine Liquid Unit Dose Cups Company Announcement American Health Packaging is voluntarily recalling eight lots of Ranitidine…
Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks
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 Other cybersecurity issues related to specified Medtronic MiniMed Insulin Pumps were communicated in the FDA Safety Communication from June 27, 2019. Recalled Product MiniMed Model 500 and 503 Remote…
Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity
Summary Company Announcement Date: November 06, 2019 FDA Publish Date: November 06, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) Company Name: Aurobindo Pharma USA, Inc. Brand Name: Brand Name(s) Aurobindo & DG Health Product Description: Product Description Ranitidine FDA Announcement Aurobindo Pharma USA, Inc. is conducting a voluntary recall of…
Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm
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 Recalled Product(s): ROSA Brain v3.0.0.0 and v3.0.0.5 Product Codes: See a full list Manufacturing Dates: February 23, 2016 to December 21, 2018 Distribution Dates: April 8, 2016…
Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues
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 CentriMag Acute Circulatory Support System Lot numbers: L05333-0001 – L06608-0024 Distribution Dates: November 22, 2017 – August 6, 2019 Devices Recalled in the U.S.: 381 Date Initiated…