Class II · Moderate risk Terminated
Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube
Reason Lack of Processing Control
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Progesterone 200 mg Capsules 90 capsules
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Progesterone/Versa Base 20 mg
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Estradiol 1.8 mg capsule 30 cap bottle
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Testosterone w/ Atrevis 100 mg/mL GEL
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Testosterone w/ Atrevis 20 mg
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Estradiol Vag Cream 0.01% Cream 30 gm tube
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Estradiol/Progesterone/Testosterone 1.5/100/1.25 mg/mL Cream 30 gm tube
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Naltrexone
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Fluorouracil
Reason Lack of Processing Control
Class II · Moderate risk Terminated
Testosterone W/Cosmetic HRT Base 100 MG
Reason Lack of Processing Control
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