Class II · Moderate risk
Cooling Menthol Extra Strength Pain Relief Patch
cGMP Deviations
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.
Class II · Moderate risk
Parche Leon Pain Relieving Hot Patch
cGMP Deviations
Class II · Moderate risk
Cheeky Bonsai Pain Relief Patches
cGMP Deviations
Class II · Moderate risk
Jr Watkins Cooling Pain Relief Patches
cGMP Deviations
Class II · Moderate risk
LILAS Feminine Pain Relief Patch
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
HealthWise PERIOD PATCH Menstrual Pain Relief
cGMP Deviations
Class II · Moderate risk
THERACARE Cold Hot Medicated Patch
cGMP Deviations
Class II · Moderate risk
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
cGMP Deviations
Class II · Moderate risk
Absorbine Jr Pain Relieving Knee Patch
cGMP Deviations
Class II · Moderate risk
ABSORBINE jr ULTRA STRENGTH PAIN PATCH
cGMP Deviations
Class II · Moderate risk
ABSORBINE jr. Extra Large BACK PATCH
cGMP Deviations
Class II · Moderate risk
Ramipril Capsules USP 10 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Ramipril Capsules USP 2.5 mg
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Class II · Moderate risk
Chlorpheniramine Maleate 4 mg tablets
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Tablets 30 mg
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cisplatin Injection
Failed Impurities/Degradation Specifications.
Class I · High risk
Ascorbic Acid Inj. Solution
Presence of Particulate Matter: Presence of glass particulates.
Class II · Moderate risk
Thiamine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
EPINEPHrine 0.9% Sodium Chloride Injection USP
cGMP violations