Acthar Gel recall — FDA D-0340-2024
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
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.
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male…
CGMP Deviations: Potential Glass and Silicone particulates in product
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Toyota Motor Engineering & Manufacturer (Toyota) is recalling certain 2022-2023 Tacoma vehicles. The axle shaft sub-assembly may separate from the axle housing due to debris causing…
Nissan North America, Inc. (Nissan) is recalling certain 2024 Titan, Frontier, Infiniti QX60, Pathfinder, 2023-2024 Sentra, Versa, Kicks, Infiniti QX50, and 2023 Rogue vehicles. Due to a…
Tesla, Inc. (Tesla) is recalling certain 2013, 2018-2021 Model S, 2020-2021 Model X, 2018-2022 Model 3, and 2020-2022 Model Y vehicles. A factory reset muted the Pedestrian Warning System…
Kia America, Inc. (Kia) is recalling certain 2020 Telluride vehicles. The high beam headlights may fail.
Ford Motor Company (Ford) is recalling certain 2022-2023 Maverick Hybrid vehicles. The Instrument Panel Cluster may not properly illuminate warning lights or gauges. As such, these vehicles…
Ford Motor Company (Ford) is recalling certain 2023-2024 Bronco and Bronco Heritage vehicles. The rear quarter glass panels may have been improperly installed to the vehicle hard top, which…
General Motors, LLC (GM) is recalling certain 2023 Chevrolet Colorado and GMC Canyon vehicles. The front camera module (FCM) system may falsely detect an obstacle, causing the automatic…
Chrysler (FCA US, LLC) is recalling certain 2022-2023 Ram Promaster vehicles. The driver seat belt warning light and audible chime may not activate as intended. As such, these vehicles fail…
Chrysler (FCA US, LLC) is recalling certain 2023-2024 Jeep Grand Cherokee and Jeep Grand Cherokee L vehicles. When the master headlight switch is set to the AUTO position, the driver may be…
Chrysler (FCA US, LLC) is recalling certain 2021-2023 Jeep Grand Cherokee L and 2022-2023 Jeep Grand Cherokee vehicles. The upper control arm ball joint and steering knuckle may separate…
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there…
GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator…
GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator…
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to…
GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator…
The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative…
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