Teva Pharmaceuticals USA Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine recall — FDA D-0469-2023
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
CGMP Deviations: Potential risk of Cross Contamination
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
CGMP Deviations: Potential risk of Cross Contamination
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Hyundai Motor America (Hyundai) is recalling certain 2021-2023 Palisade vehicles. The windshield wiper motor may operate intermittently or fail to operate due to snow or ice buildup on the…
Hyundai Motor America (Hyundai) is recalling certain 2019-2023 Santa Fe, 2021-2023 Santa Fe HEV, 2022-2023 Santa Fe Plug-in HEV and Santa Cruz vehicles potentially equipped with a tow hitch…
General Motors, LLC (GM) is recalling certain 2023 Cadillac XT6, GMC Acadia, Chevrolet Blazer, Traverse, and 2022-2023 Cadillac XT5 vehicles. The transmission may have been built with an…
Honda (American Honda Motor Co) is recalling certain 2020-2021 Pilot and Ridgeline, and 2020-2022 Passport and Odyssey vehicles. The heating pads behind both side-view mirrors may not be…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the…
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
An unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may result in an interruption to therapy…
An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the…
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump…
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure…
pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure
Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model CM3000…
Browse recent months with enough recall history for useful comparison.