Class II · Moderate risk
Theracare Maximum Strength Pain Relief 4% Lidocaine Patch
cGMP Deviations
FDA Drug Recalls
11,818 recalls · Class II, newest first
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 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 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
Class II · Moderate risk
Oxytocin 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
CGMP violations
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion