Class II · Moderate risk Terminated
Testosterone W/Cosmetic HRT Base 100 MG
Reason Lack of Processing Control
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Estriol Vaginal Cream
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason 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 Terminated
Lisinopril Tablets USP
Reason 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 Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Daytrana
Reason Defective Delivery System: Out of specification for mechanical peel and shear.
Class II · Moderate risk Terminated
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 100 mg
Reason 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 Terminated
Losartan Potassium Tablets USP 50 mg
Reason 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 Terminated
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone Cypionate In Sesame Oil 200mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Hydroxyprogesterone Caproate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Mic-8
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Methylcobalamin Soln. 1000 mcg/ml
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Fentanyl Citrate Injection
Reason 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 Terminated
Thyro-H
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
BioMycin
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Worm Off
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Voice Rescue
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Vitiligo Off Ointment
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Vigo-XXX
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Vertigo Off
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Tution 130
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Class II · Moderate risk Terminated
Thyro-Lo
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs