LILAS Feminine Pain Relief Patch
cGMP Deviations
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Failed Impurities/Degradation Specification
Failed Impurities/Degradation Specification
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Labeling: Label Mix-Up
Labeling: Label Mix-Up
CGMP Deviations
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit