Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk Terminated
Telmisartan and Hyrdochlorothiazide Tablets
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk Terminated
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II · Moderate risk Terminated
Tamsulosin Hydrochloride Capsules
Reason Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class II · Moderate risk Terminated
Gentamicin Sulfate Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.44-0.64mg-5.8mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.44-0.58mg-5.8mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 15-0.25mg-6mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1 Mg-20 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 9-1 Mg-10 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 22.5-0.8mg-8.3mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.64-0.58mg-5.88mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 16.6-0.55 Mg-11.1 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 15-0.5mg-10mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-2 Mg-30 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 30-0.5 Mg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 15-0.5mgmg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Pge1-Lidocaine 40 Mcg-1% /Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1.6 Mg-16 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 23-0.96mg-19.2mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 17.16-0.57mg-19.45mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 12-1mg-10mcg/Ml Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine-Pge1 30-1 Mg-10 Mcg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk Terminated
Papaverine-Phentolamine 30-1 Mg/Ml* Injectable
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.