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.
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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…
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Non-Sterility
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.
Ford Motor Company (Ford) is recalling certain 2023 Maverick vehicles. A missing electrical circuit may cause the trailer taillights to not illuminate as intended when utilizing the vehicle…
Ford Motor Company (Ford) is recalling certain 2021-2022 Bronco vehicles equipped with 8-inch SYNC infotainment screens that were previously remedied under recall 22V-825. The rearview…
Ford Motor Company (Ford) is recalling certain 2021 F-150 vehicles. The windshield wiper arms may break, causing the windshield wipers to fail.
Honda (American Honda Motor Co.) is recalling certain 2017-2020 CR-V, 2018-2019 Accord and Accord Hybrid, 2018-2020 Odyssey, 2019 Insight, and 2019-2020 Acura RDX vehicles. A manufacturing…
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