SODIUM BICARBONATE 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 recall — FDA D-0116-2024
Presence of Particulate Matter: Silicone
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Presence of Particulate Matter: Silicone
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
Presence of Particulate Matter: Silicone
Ford Motor Company (Ford) is recalling certain 2024 Mustang vehicles. The brake pedal assembly may have been manufactured incorrectly, which can result in a loose brake pedal.
Ford Motor Company (Ford) is recalling certain 2022 F-150 vehicles. The parking lights may flicker when the headlights are activated. As such, these vehicles fail to comply with the…
Chrysler (FCA US, LLC) is recalling certain 2023 Ram 1500 Classic, Ram 3500 Classic, 3500 Cab Chassis, 2023-2024 Ram 2500, 4500/5500 Cab Chassis, and Ram 3500 vehicles. The steering column…
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good…
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good…
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good…
Nissan North America, Inc. (Nissan) is recalling certain 2021 Rogue vehicles. The left and/or right rear brake caliper assemblies may be missing an internal bushing, allowing the O-ring…
Chrysler (FCA US, LLC) is recalling certain 2021-2023 Jeep Wrangler Plug-In Hybrid Electric (PHEV) vehicles. The high voltage battery may fail internally and lead to a vehicle fire while…
Volvo Car USA, LLC. (Volvo Car) is recalling certain 2019-2024 S60 vehicles. The passenger air bag may not be secured properly, which can cause the air bag to deploy improperly.
Honda (American Honda Motor Co.) is recalling certain 2023-2024 Accord and HR-V vehicles. The front seat belt pretensioners may be missing the rivet that secures the quick connector and…
Presence of Particulate Matter: identified as glass.
Failed Dissolution Specifications: Out of specification for dissolution.
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active…
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay…
Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
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