Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
708 recalls · Class II, newest first
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Dutasteride Capsules
Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
Class II · Moderate risk
Ranitidine Capsules 150 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Capsules 300 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine
CGMP Deviations: Presence of NDMA impurity detected in product.