CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
All Recalls
95,025 total recalls in our database
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
💊 Drugs Class I - Dangerous
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Real Clean Distribuciones SA de CV
💊 Drugs Class I - Dangerous
Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02
Real Clean Distribuciones SA de CV
💊 Drugs Class I - Dangerous
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL OZ (1L) bottle, UPC 8 40038 21447 1; Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Real Clean Distribuciones SA de CV
💊 Drugs Class I - Dangerous
CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
💊 Drugs Class I - Dangerous
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
💊 Drugs Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
💊 Drugs Class I - Dangerous
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
💊 Drugs Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
💊 Drugs Class I - Dangerous
Subpotent Drug: FDA analysis found product to be subpotent
scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1
Real Clean Distribuciones SA de CV
💊 Drugs Class I - Dangerous
CGMP Deviations: Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
🏥 Medical Devices Class I - Dangerous
Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%.
🏥 Medical Devices Class I - Dangerous
The firm has received reports concerning the patient fiducial disk separating from the body and users attempting to re-assemble the device. The use of a re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
Maquet Cardiovascular Us Sales
🏥 Medical Devices Class I - Dangerous
Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
🏥 Medical Devices Class I - Dangerous
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
🏥 Medical Devices Class I - Dangerous
lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.