Class II · Moderate risk Terminated
Aspirin and Extended-release Dipyridamole Capsules
Reason Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Class II · Moderate risk Ongoing
Losartan Potassium Tablets
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Class II · Moderate risk Completed
Drospirenone and Ethinyl Estradiol Tablets
Reason Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Class II · Moderate risk Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets
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 Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets
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 Ongoing
Losartan Potassium / Hydrochlorothiazide Tablets
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 Ongoing
Losartan Potassium Tablets
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 Ongoing
Losartan Potassium Tablets
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 Ongoing
Losartan Potassium Tablets
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 Ongoing
Losartan Potassium Tablets USP
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Class II · Moderate risk Ongoing
Losartan Potassium Tablets USP
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
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.