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Prescription drugs recalled for contamination, potency or labelling.
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2,102 recalls · newest first
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Out of Specification for Dissolution
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Presence of Particulate Matter.
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
cGMP Deviations: Product intended for quarantine was inadvertently distributed.
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Superpotent; sodium benzoate preservative
Presence of Foreign Tablets/Capsules
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.