💊 Drugs Class I - Dangerous
CGMP Deviations
All Recalls
95,114 total recalls in our database
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
Specialty Process Labs
💊 Drugs Class I - Dangerous
Failed Stability Specifications
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Amneal Pharmaceuticals of New York
💊 Drugs Class I - Dangerous
Superpotent Drug: Due to overfilling of drug powder
Ingenia 1.5T S, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics
🏥 Medical Devices Class I - Dangerous
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
🏥 Medical Devices Class I - Dangerous
Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World (ROW) countries. The difference between the US IFU and the ROW IFU is the addition of an intended use section in the ROW IFU.
Achieva 1.5T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Achieva 3.0T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
🏥 Medical Devices Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
ACTIM OY
🏥 Medical Devices Class I - Dangerous
Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.
AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
SonarMed
🏥 Medical Devices Class I - Dangerous
Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor.
GYROSCAN T5-NT, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 1.5T, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
🏥 Medical Devices Class I - Dangerous
The failure to detect the partial obstruction in a 2.5mm sensor.
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Philips North America
🏥 Medical Devices Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
SonarMed
🏥 Medical Devices Class I - Dangerous
The failure to detect the partial obstruction in a 2.5mm sensor.
🏥 Medical Devices Class I - Dangerous
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.