💊 Drugs Class I - Dangerous
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
All Recalls
95,075 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
💊 Drugs Class I - Dangerous
Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
💊 Drugs Class I - Dangerous
Presence of a foreign substance: black hair found embedded in tablet.
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
🏥 Medical Devices Class I - Dangerous
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
🏥 Medical Devices Class I - Dangerous
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Fresenius Kabi USA
🏥 Medical Devices Class I - Dangerous
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Philips North America
🏥 Medical Devices Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
🏥 Medical Devices Class I - Dangerous
Due to non-sterile products being labeled as sterile
🏥 Medical Devices Class I - Dangerous
Sterility assurance for Ophthalmic knives.
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
BD SWITZERLAND SARL
🏥 Medical Devices Class I - Dangerous
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
🏥 Medical Devices Class I - Dangerous
Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis.
🏥 Medical Devices Class I - Dangerous
Software issue that could potentially lead to the device tipping over from Balance Mode.
🏥 Medical Devices Class I - Dangerous
Unreleased software versions were installed on distributed devices without verification or validation.
🏥 Medical Devices Class I - Dangerous
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
🏥 Medical Devices Class I - Dangerous
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
🏥 Medical Devices Class I - Dangerous
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.