Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
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92,900 total recalls in our database
Potential Listeria monocytogenes contamination
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
The product was found to have Listeria monocytogenes
Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
BLI International
Superpotent Drug: Stability failure for assay at 6 months test time-point.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Dr. Reddy's Laboratories
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Dr. Reddy's Laboratories
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Dr. Reddy's Laboratories
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Olympus Corporation of the Americas
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods
The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Abbott Molecular
Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.
Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Maquet Cardiovascular
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing.
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Nihon Kohden America
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.