Class II · Moderate risk
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube
Lack of Processing Control
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Fluorouracil
Lack of Processing Control
Class II · Moderate risk
Testosterone W/Cosmetic HRT Base 100 MG
Lack of Processing Control
Class II · Moderate risk
Estriol Vaginal Cream
Lack of Processing Control
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class II · Moderate risk
Losartan Potassium Tablets USP 100 mg
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Class II · Moderate risk
Losartan Potassium Tablets USP 50 mg
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Class II · Moderate risk
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate In Sesame Oil 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Soln. 1000 mcg/ml
Lack of Assurance of Sterility
Class III · Low risk
Fentanyl Citrate Injection
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Class II · Moderate risk
Thyro-H
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
BioMycin
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Worm Off
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk
Voice Rescue
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs