Class II · Moderate risk Terminated
LILAS Feminine Pain Relief Patch
Reason cGMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine…
Reason cGMP Deviations
Class II · Moderate risk Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief
Reason cGMP Deviations
Class II · Moderate risk Terminated
THERACARE Cold Hot Medicated Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
Absorbine Jr Pain Relieving Knee Patch
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr ULTRA STRENGTH PAIN PATCH
Reason cGMP Deviations
Class II · Moderate risk Terminated
ABSORBINE jr. Extra Large BACK PATCH
Reason cGMP Deviations
Class II · Moderate risk Terminated
Ramipril Capsules USP 10 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 5 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Terminated
Ramipril Capsules USP 2.5 mg
Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Lanthanum Carbonate Chewable Tablets
Reason Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 30 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Ongoing
Morphine Sulfate Extended-Release Tablets 15 mg
Reason Failed Impurities/Degradation Specification
Class II · Moderate risk Terminated
Chlorpheniramine Maleate 4 mg tablets
Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Sunitinib Malate Capsules
Reason Labeling: Label Mix-Up
Class II · Moderate risk Ongoing
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution
Reason Subpotent Drug
Class II · Moderate risk Ongoing
OneLAX Docusate Sodium Liquid
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Tablets 30 mg
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Completed
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets
Reason CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit