Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90) recall — FDA D-0287-2021
Failed Dissolution Specifications
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Failed Dissolution Specifications
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile…
Nissan North America, Inc. (Nissan) is recalling certain 2016-2019 Nissan Sentra vehicles. The brake light switch may become contaminated, preventing the circuit from closing and the brake…
General Motors LLC (GM) is recalling certain 2020 Buick Enclave, Cadillac XT4, XT5, Escalade, Escalade ESV, Chevrolet Suburban, Tahoe, Traverse, GMC Yukon, Yukon XL, 2018-2021 Chevrolet…
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test…
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation…
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Due to two (2) issues: 1) The firm distributed COVID-19 Rapid Test Cassettes outside of the Emergency Use Authorization to non-certified Clinical Laboratories. 2) COVID-19 Rapid Test…
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
GE Healthcare has become aware of a potential issue on Revolution Apex, Revolution CT with Apex Edition, Revolution CT, and Revolution CT ES systems where the table pinch protector could be…
Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirulina elicit unusually high 13CO2-excretion rates
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary…
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus
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