Nelarabine Injection, 250mg/50mL, (5mg/mL) recall — FDA D-0255-2025
Failed Impurities/Degradation Specifications
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
754 detailed records are currently available in this category.
Failed Impurities/Degradation Specifications
Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lack of Assurance of Sterility: due to a quality control process deviation
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Failed Dissolution Specifications.
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin (epinephrine injection, USP)
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
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